12 Quality Control Analyst jobs in Ireland

Quality Control Analyst

Waterford, Munster Cpl Resources

Posted 1 day ago

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We are currently seeking a QC Analyst with previous industry experience to join our client's site in Waterford on an initial 12 months contract. Key responsibilities: Provide analytical chemistry services and support to Site. Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases. In particular, close contact maintained with Quality Assurance Production, Engineering and Planners. Maintain, update and issue chemical methods, specifications and SOPs in compliance to pharmacopoeial and regulatory requirements. Assist with training of the analysts in areas of expertise and knowledge and in new methods, SOPs and updates. Trend such results, record on COAs where required and complete OOSs investigations on a timely basis. Update the QC Team Leader on potential problems and highlight improvements where possible by use of the normal communication means. Ensure all quality documentation and records are complete and current. Ensure QC laboratories meet current Good Laboratory Practice (cGLP) requirements. Ensure relevant procedures are correctly defined and followed. Ensure that critical chemical testing and related equipment meets current validation requirements (IQ, OQ, PQ) where required. Audit and review chemistry test results on a daily basis and ensure compliance with cGLP. Checking/auditing laboratory notebooks and analytical reports Ensure compliance to cGMP at all times. Qualifications: Degree in Science (Chemistry or Biochemistry preferred). Postgraduate studies as appropriate to augment primary degree. 2-3 years experience working in a manufacturing environment ideally part of which would be in the pharmaceutical sector. Experience with some of the following tests: HPLC/UPLC, SDS-PAGE, Karl Fischer, HIAC, micro pipetting and ELISA. Skills: HPLC GMP Karl Fisher SDS-PAGE ELISA
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QA Regulatory Compliance Specialist

PCI Pharma Services

Posted 28 days ago

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Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
The role is to implement and execute tasks relating to the introduction and maintenance of Clinical products within the RCT department in PCI. Role supports right first time QP release and clients in management and oversight of regulatory changes.
+ Creation and maintenance of Product Specification File (PSF) for Clinical supply chain where QP certification is performed.
+ Developing and managing Quality Systems & Compliance to support the maintenance and release of third-party supply chains at PCI.
+ Maintenance of Approved CMO list for Clinical Supply Chain
+ Ensure on-going compliance with customer, regulatory and internal requirements.
+ Management and co-ordinate Supplier Management Programme, including supplier audits, preparation and review of quality technical agreements, supplier qualification and vendor performance for third party suppliers.
+ Preparation and maintenance of the clinical approved products.
+ Preparation of QP declarations for review and approval by PCI QP
+ Support the management of the Manufacturing and Importation Licence held by Millmount entity and the associated variations to it.
+ Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to management.
+ Generation of SOP/Forms/Job Aids/Work Instruction's on the Master Control system
+ Identify and support opportunities for improving processes and or procedures.
+ To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
**Knowledge / Skills & Experience**
**Essential:**
+ Bachelor's degree in a scientific/technical/engineering discipline or associate degree or Diploma / Certificate. May substitute experience in lieu of educational requirements.
+ Minimum 2 years' experience working in quality, validation or compliance role within the biological and/or pharmaceutical industry.
+ Knowledgeable of EU regulatory requirements applicable to pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
+ Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
+ Client Facing experience
**Desirable:**
+ Experience in auditing of external suppliers, contractors and vendors.
+ Experience with regulatory filings.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
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Principal Regulatory Compliance Specialist

Dublin, Leinster Oracle

Posted 28 days ago

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**Job Description**
Oracle Cloud Infrastructure (OCI) is seeking a highly skilled and detail-oriented Regulatory Compliance Specialist to join our dynamic team. As a key player in our global organization, you will be responsible for managing audits and assessments, and informing OCI on regulatory changes so that we maintain a high level of compliance and adhere to all relevant regulations, policies, and standards.
We are looking for a Regulatory Compliance Specialist who is looking to grow their career in Cloud. You will be responsible for the support and implementation of scalable audit programs to support Oracle Cloud Infrastructure's growth in regulated markets within the Europe, Middle East, and Africa (EMEA) region with a specific focus on Europe.
The ideal candidate will have the following skills:
· 8+ years audit program management experience with either a "Big 4" accounting firm, or a mid-level accounting firm.
· 4+ years proven experience as a Regulatory Compliance Specialist or similar role.
· Knowledge of industry and regulatory frameworks is preferable, such as ISO 27000 Series, SOC 1, SOC2, ENS, ACN, Cyber Essentials+, EU CoC, TISAX, etc.
· Strong analytical and problem-solving skills.
· Excellent communication and interpersonal abilities.
· Ability to work collaboratively with cross-functional teams.
· Possess ability to explain complex auditing topics to audiences with no auditing experience.
· Ability to prioritize, manage, and deliver on multiple projects simultaneously and partner with management in support of key initiatives and projects.
· Strong bias toward action, flexible, resourceful, and able to operate effectively within a dynamic, fast-paced environment.
· Superior communication skills (interpersonal, verbal, presentation written, email, tickets, etc.)
Preferred Qualifications:
· JIRA and Confluence experience strongly preferred.
· Professional certification in regulatory compliance (i.e. PMP, PgMP, CISA, CISM, CISSP, CIPP)
#LI-DNI
**Responsibilities**
Responsibilities:
Manage Audits and Assessments:
· Plan, manage, and conduct regular compliance audits with third party auditors.
· Communicate OCI processes and policy to third party auditors effectively.
· Report findings and recommend corrective actions as needed across different stakeholder groups.
· Foster a culture of compliance awareness through regular communication and educational initiatives.
· Effectively communicate in remote working environment over video, phone, email and other tools.
Stay Informed on Regulatory Changes:
· Monitor and stay up-to-date on changes to local, national, and international regulations affecting cloud service providers in EMEA, specifically within Europe.
· Analyze the impact of regulatory changes and provide recommendations to the management team.
· Conduct regular reviews and updates of existing policies to ensure ongoing relevance.
Regulatory Reporting:
· Prepare and submit timely and accurate regulatory reports to relevant authorities in accordance with applicable regulations.
· Work closely with internal teams to gather necessary data and information for reporting purposes.
· Provide clear expectations and direction to security and engineering teams within OCI on audit requirements.
Career Level - IC4
**About Us**
As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity.
We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all.
Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.
We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing or by calling +1 in the United States.
Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
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Quality & Regulatory Compliance Specialist

Dublin, Leinster Independent Search Solutions

Posted 10 days ago

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My client who is a Large and Diversified Medical Device and Pharmaceutical Distribution business has a role for a Quality & Regulatory Compliance Specialist. I am particularly keen to speak with Quality & Regulatory Talent who are coming from a Distribution environment and have a good understanding of Good Distribution Practice (GDP) but I am open to considering people from a range of Compliance backgrounds (Pharma / Medical Device Sector). You will also ideally be Responsible Person Eligible along with being a qualified Pharmacist. Based in South Dublin this successful business offers good career progression opportunities for a dynamic and hardworking Specialist who wishes to further their career through professional development APPLY TODAY Quality Specialist / Regulatory Specialist / Compliance / Good Distribution Practice / Pharmacist / Pharmacovigilance / Responsible Person / Quality Management Systems / Audits / MDR / IVDR /ISO 9001 / ISO 13485/ South Dublin / Ireland Job Title: Quality & Regulatory Specialist Reports To: Quality & Regulatory Lead (Pharma & Medical Device) Location: South Dublin Offices Package: Permanent / Full Time €45k - €5k Basic (Dependent on Experience & Open to Negotiation) Annual Bonus Pension Parking Canteen Paid Annual Leave Educational Assistance ( Role: The Quality Compliance Pharmacist is responsible for ensuring compliance with Good Distribution Practice (GDP) and regulatory requirements across pharmaceutical and medical device operations. This includes support of Quality Systems, Product Release, Validation, and Supplier Management. The role involves maintaining Regulatory Licenses, Managing Pharmacovigilance and Vigilance Activities, Handling Audits and CAPAs, and ensuring up-to-date Documentation and Training Programs. You will also support compliance with MDR/IVDR, oversees Change Control Processes, and ensures products meet Quality Standards before distribution, working cross-functionally with internal teams and external partners. The position will also support Regulatory, Medical Information and Pharmacovigilance requirements as applicable. Duties and Responsibilities: Quality Management & Compliance: Oversee Good Distribution Practice (GDP) activities for pharmaceutical and medical device products Ensure temperature control and environmental monitoring of storage and distribution areas Manage quality operations, including deviation/NC handling, root cause analysis, and implementation of corrective and preventive actions (CAPAs) Perform risk assessments for distributed products and processes in line with regulatory and company standards Maintain and control documentation, including SOPs, records, and batch release documents Lead and participate in internal and external audits, including preparation, execution, and follow-up on findings Regulatory: Prepare, submit, and maintain facility licenses, registrations, and renewals with national and international regulatory bodies Oversee compliance with Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements Monitor regulatory updates and assess business impact (regulatory intelligence) Review and approve product labelling, promotional materials, and advertising to ensure regulatory compliance Pharmacovigilance & Safety: Manage pharmacovigilance and medical device vigilance activities, including adverse event reporting and follow-up Handle product complaints and coordinate recalls in line with regulatory expectations and internal procedures Validation & System Control: Oversee validation of systems, equipment, and processes involved in distribution Ensure compliance with data integrity Training & Development: Develop, maintain, and deliver training programs to ensure all staff comply with GDP, GMP, and quality policies Ensure training records are complete and up to date Supplier & Warehouse Oversight: Qualify and manage suppliers and third-party service providers, including audits and performance monitoring Support warehousing operations to ensure GDP compliance, including good housekeeping, pest control, and material handling Product Release: Ensure that pharmaceutical and medical device products meet quality and regulatory standards prior to release for distribution Change Control: Manage the change control process for systems, products, and procedures, assessing potential risks and regulatory impacts Experience: Qualified Pharmacist Responsible Person eligibility 1-3 Years working in a similar role; Quality, Compliance (Pharma / Medical Device Business) Auditor Certified (e.g., ISO 9001 and/or ISO 13485 or Pharma Equivalent) Strong knowledge of GDP, GMP, MDR, IVDR, and Local Regulatory Framework 1-3 years experience in Regulatory, Medical information or Pharmacovigilance If you would like to be considered for this fantastic opportunity follow the links below and send me your CV. Key Words: Quality Specialist / Regulatory Specialist / Compliance / Good Distribution Practice / Pharmacist / Pharmacovigilance / Responsible Person / Quality Management Systems / Audits / MDR / IVDR / ISO 9001 / ISO 13485 / South Dublin / Ireland Independent Search Solutions (ISS Ltd) is as the name suggests an Independent Recruitment Agency that aims to treat all its applicants with the up-most respect and in a professional manner. With a Company code of practice in place, you can be assured that your details will not be shown to any of ISS Ltds clients without your consent. Skills: Pharmacist Quality Specialist Regulatory Specialist Compliance Specialist Good Distribution Practice Quality Audit Pharmacovigilance Benefits: Annual Bonus / 13th Cheque Group Life Assurance Laptop Parking Pension Fund Performance Bonus Work From Home
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Senior Analyst, Laboratory Quality Control

Sligo, Connacht AbbVie

Posted 5 days ago

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Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
What you do, is what we need. Making a difference begins here. And takes all of us.
Welcome to AbbVie!
We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.
We are recruiting a Senior Laboratory Analyst to join our QC team on site in Manorhamilton Road, Sligo on a rotational shift pattern.
In your role as a Senior Laboratory Analyst, you will be responsible for providing an effective and analytical service to the plant ensuring that that products manufactured are tested to specification on time and plant quality and safety goals are met. This position will take responsibility for ensuring the timely testing and release of all raw materials, in-process, finished product, stability and contract testing. The senior analyst position is also responsible for ensuring all activities are carried out per schedule and records are maintained to appropriate requirements, they must also ensure that technical and systems excellence is maintained in the laboratory by ensuring own skills are maintained and implementing improved working practices in terms of efficiency, compliance and Right First Time.
What you will do:
+ Ensure Laboratory Documentation and Computerized Systems compliance with Data Integrity policies and regulatory requirements.
+ Understand Regulations and business processes required to maintain Laboratory Data Integrity.
+ Ensure timely completion of all laboratory analysis assigned to shift.
+ Ensure that analysts working in the assigned cell or team are performing to the best of their ability, coaching and providing guidance where issues occur such as poor set-up or test execution performance.
+ Improve the overall efficiency and velocity within the assigned team.
+ Identify and implement improvements in analytical practices using 'Zero, Believe it, Achieve it'
+ Ensure that the agreed test schedule is adhered to and identifying recovery paths to bring test schedules back into alignment with plant requirements.
+ Identify weaknesses in laboratory performance and working with the laboratory Supervisors to rectify.
+ Support & initiate analytical OOS issues as they arise in a timely manner both through practical work and through Soltraqs.
+ Act as designee for the Laboratory Supervisor as assigned.
+ Ensure 6S excellence is maintained across the Laboratory.
+ Instill a quality culture of Zero, Believe it, Achieve it amongst the QC laboratory team
+ Ensure that all laboratory test equipment is utilised and maintained correctly.
+ Maintain up-to-date, complete and precise records of all tests performed.
+ Act as the primary point of contact for any analytical issues which arise.
+ Developing and changing of in-house laboratory procedures as appropriate.
Qualifications
What you will need:
+ 3rd level qualification in relevant Science discipline
+ Minimum 4 years' experience in Pharma industry
+ Strong knowledge of regulatory requirements
+ Must have strong knowledge of HPLC, GC,LCMS, GCMS, Automatic titration and Identification techniques.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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Pharmacovigilance Data Analysis Manager

Dublin, Leinster Grifols Shared Services North America, Inc

Posted 18 days ago

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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
**We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunity fostering an inclusive environment where diversity makes us be outstanding.**
Help us lead one of the world's largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That's why we need a _Pharmacovigilance Data Analysis Manager_ like you.
Role Mission: Provide operational support for global pharmacovigilance activities related to Grifols' investigational and marketed products. Ensure high-quality pharmacovigilance deliverables that comply with global regulatory reporting timelines. Manage project implementation and execution of safety systems, including ongoing business support and continuous improvement initiatives. Act as a key liaison with IT system administrators to validate and test system changes, ensuring compliance and alignment with business needs.
**What your responsibilities will be**
+ Lead and coordinate safety data analysis for aggregate reports preparation, signal management and ad hoc requests.
+ Support drug safety systems through business administration tasks, including database configuration updates, submission rules management and testing with regulatory authorities.
+ Serve as a subject matter expert in delivering and evaluating cost-effective, sustainable solutions that meet business requirements.
+ Manage documentation related to PV systems and applications, including SOPs, WPs, user requirements, functional/ technical specifications and process flow diagrams.
+ Drive change management initiatives to ensure smooth adoption of new processes and support the integration of new applications within the PV team.
+ Collect, prioritize and plan system improvements based on user feedback, while ensuring compliance with regulatory requirements.
+ Act as the primary PV contact for IT-related PV projects.
+ Drive Innovation through AI in Pharmacovigilance: Stay at the forefront of artificial intelligence advancements to identify and evaluate innovative technologies and processes that can enhance pharmacovigilance operations. This includes proactively assessing AI-driven tools and methodologies to improve signal detection, case processing, data analysis and regulatory compliance. Collaborate cross-functionally to pilot and implement solutions that increase efficiency, accuracy, and strategic value in safety monitoring.
**Who you are**
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
+ You have a bachelor's degree in Health Sciences (pharmacy, nursing, medicine, veterinary, etc) or Bioscience (biochemistry, biotechnology, biology, etc). Additional training and/or experience in bioinformatics/biostatistics or data analysis tools (such as R or Power BI).
+ You have at least 4 years of pharmacovigilance experience including management of pharmacovigilance data bases.
+ You have proven knowledge of Good Pharmacovigilance Practices; existing legislation, regulations, guidelines, medical coding and safety-data administration.
+ You are proficient in Windows and MS Office (Excel, PowerPoint, Visio, Word).
+ Familiarity with reporting tools such as Business Objects is strongly preferred.
+ You have knowledge of E2b (R2) and E2b (R3) and to be familiarity with medical terminology, MedDRA, WhoDrug are a plus.
+ You speak fluent Spanish and English.
+ You are proven self-starter with strong work ethic and the ability to exercise good judgment.
+ You must be proactive, results oriented and have strong attention to detail.
+ Strong organizational, analytical and problem-solving skills with the ability to make structured decisions on a routine basis.
+ Strong interpersonal skills with the ability to interact and collaborate with personnel at all levels in a team environment.
+ You possess strong technical writing and communication skills with ability to create and present design proposals, test scripts, execute training sessions and conduct effective meetings.
+ Ability to effectively prioritize and manage multiple tasks to ensure successful completion targeted deadlines.
**What we offer**
It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
Information about Grifols is available at If you are interested in joining our company and you have what it takes for such an exciting position, then don't hesitate to apply!
We look forward to receiving your application!
**We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.**
Grifols is an equal opportunity employer.
**Flexible schedule:** Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time).
**Benefits package**
**Contract of Employment:** Permanent position
**Flexibility for U Program:** Hybrid
**Location:** Sant Cugat del Vallès (preferably) / Other locations as Los Angeles, Clayton or Dublin will be considered
more about Grifols
**Req ID:** 531655
**Type:** Indefinido tiempo completo
**Job Category:** I + D
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Manager, Quality Control

Sligo, Connacht AbbVie

Posted 5 days ago

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Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
We are looking for a QC Manager to join our team on our Manorhamilton Road site in Sligo. The QC Lab Manager is integral to managing a team responsible for QC testing, ensuring adherence to product specifications, quality, and safety goals. This role involves overseeing laboratory operations, including analytical testing for API and OSD products, and coordinating with internal teams to meet testing schedules.
Responsibilities:
+ Manage a lab team performing QC testing, ensuring compliance with data integrity policies and regulatory requirements.
+ Conduct and supervise all aspects of API and OSD analytical testing.
+ Ensure timely sampling, inspection, and testing, coordinating with teams for schedules and priorities.
+ Participate in internal and external audits and address audit findings.
+ Prepare technical reports, lead investigations, and implement CAPAs.
+ Provide training and support to lab team to achieve daily and long-term goals.
+ Present technical data to stakeholders to facilitate prompt decision-making.
+ Report to the Senior QC Manager.
Qualifications
+ M.Sc./B.Sc. in Chemistry or a related discipline.
+ Minimum 4 years of experience in people management within a pharmaceutical lab setting.
+ Strong knowledge of QA/QC operations, analytical testing for API and OSD.
+ Excellent presentation and technical report writing skills.
+ Strong communication and interpersonal skills, with a commitment to quality and compliance.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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Manager Quality Control

Limerick, Munster Regeneron Ireland DAC

Posted 1 day ago

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Within this role you will be responsible for the oversight of Quality Control support operations. As a Manager within Quality Control a typical day might include, but is not limited to, the following: Maintaining oversight of QC equipment lifecycle activities (including procurement, installation, qualification, maintenance, and decommissioning) Providing direction to Managers and staff that support the equipment Ensuring equipment qualification and maintenance programs are aligned with regulatory agencies requirements, qualified and available for QC laboratory usage Interacting with QC partner groups to establish internal requirements for equipment Leading QC equipment validation / qualification efforts through partnering and interaction with QA Validation and IT groups Managing oversight of the preventive and corrective maintenance monitoring program Managing oversight of the QC external laboratories activities and performance monitoring of external testing laboratories Supervising the issuance and approval of Quality agreements and SLAs with the contract labs Verifying that the site Manufacturing licence and global procedures reflect current contract lab utilization Identifying and calling out issues at contract laboratories to QC leadership Sourcing, co-ordinating and project management of GMP activities relating to new contract lab introduction Travel may be required in support of external contract laboratory testing activities Performing personnel management functions including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations Responsibility for equipment automation and associated projects This role might be for you if you: Possess strong communication and interpersonal skills Demonstrate logical troubleshooting and problem-solving skills Have a detailed understanding of equipment qualification and maintenance activities and industry compliance norms Have the ability to communicate effectively with multiple partners Enjoy working in a fast-paced environment Demonstrate a collaborative and team-orientated approach To be considered for this opportunity you should have a BA/BS in chemistry, biology or related field with 8+ years' proven experience preferably in the pharmaceutical or biotechnology industry, and previous supervisory or leadership experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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Quality Control Laboratory Apprentice

Wicklow, Leinster Takeda Pharmaceuticals

Posted 5 days ago

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By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**Job Description**
Are you looking for a patient-oriented, innovation-driven company that inspires you and promotes your career? Then take your future in your hands and become part of Takeda as a
**Quality Control Laboratory Apprentice**
This role offer unique opportunity to gain hands-on experience and comprehensive training in Quality Control (QC) practices within a cutting-edge pharmaceutical environment. Joining the team allows the applicant to develop crucial technical and soft skills while contributing to Takeda's commitment to innovation, quality, and patient-centric values. This apprenticeship fosters professional growth, teamwork, and meaningful work that impacts global healthcare.

**You will be trained to possess the following skills:**
+ Demonstrating the ability to operate equipment and instruments effectively and according to standard operating procedures (SOPs).
+ Showing the ability to work effectively in a safe manner within the laboratory.
+ Communicating the theoretical knowledge of relevant sciences and technology.
+ Handling materials and equipment correctly paying due regard to safety and environmental protection regulations.
+ Capability to perform basic chemistry techniques to include but not limited to the use of: Pipettes, Auto-Titrators, pH, Weighing, Diluting to Volume, Volumetric Calculations, Karl Fischer, Thin Layer Chromatography, and Physical Testing.
+ Ability to identify and note equipment (foe sampling, testing and control) malfunction if it occurs, and informing the QC Team Leader.
**You will acquire the following knowledge:**
+ Understanding science fundamentals, basic chemistry, microbiology, and production processes (upstream/downstream).
+ Knowledge of cGMP, quality systems, GLP/GMP deficiencies, and data integrity principles.
+ Safe lab operations, housekeeping, proper labelling, calibration, and equipment use.
+ Handling, logging, and testing of samples e.g., water, raw materials, in-process, finished products.
+ Familiarity with pharmacopoeias and investigation processes e.g., OOS.
+ Awareness of QC purchase systems, supplier coordination, and proper reporting protocols.
**You will strengthen the following soft skills:**
+ Effective communication and team work.
+ Good technical writing skills.
+ Working independently and taking responsibility for initiating and completing tasks.
+ Understanding impact of work on others, especially where related to diversity and equality.
+ Time management and ability to complete work to schedule.
+ Ability to handle change and respond to change management processes.
**How you will contribute:**
+ Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
+ Participate fully in any cross functional training initiatives.
+ Drive and promote the corporate values of Takeda-ism within the workplace.
+ Ensure timely completion of all SOP, reading, training and assessment.
+ Other duties as required and directed.
In this position you will report to the QC Team Leader.
**What you bring to Takeda:**
+ For entry into year 1 of Level 6 Quality Control Apprenticeship Programme you must have passed (Grade O6 or better) in five Leaving Certificate subjects, one of which must be math and one science related subject and gathered 250 CAO points **OR** you can also enter the Programme, if you have graduated relevant FETAC Level 5 or Level 6 and are a current employee with relevant experience and qualifications.
+ Before enrolment on the apprenticeship programme the apprentice must have SOLAS apprentice approval.
+ Health, Safety and Environmental awareness.
+ Ability to share knowledge and expertise with others.
+ Engage in teamwork.
+ Complete integrity and compliance programs.
+ Ability to work independently.
+ Problem solving & critical thinking.
+ Microsoft Office skills in MS Excel and MS Word.
+ Mathematics and statistics knowledge.
+ Proven continuous professional development.
**What Takeda can offer you:**
+ Flexible working arrangements, e.g., hybrid or shiftwork with shift allowance
+ 26 vacation days plus additional days for service milestones
+ Employee Assistance Program
+ Wellbeing and engagement teams
+ Development opportunities
+ Educational programs and formal training
+ Coaching and mentoring
+ Humanitarian volunteering leave options
+ Subsidized canteen
+ Electric charging points available at parking locations
**More about us:**
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines.
Takeda Ireland was established in 1997. Our story in Ireland is one of substantial growth, rapid change, and innovation. Over the past two years, Takeda Ireland has invested over 55 million in Ireland to develop our manufacturing sites. Solidifying our commitment in our people and contributing to the local economy. Takeda in Ireland has commercial operations, corporate services, and manufacturing facilities across four locations: Baggot St, Bray, Citywest, and Grange Castle. We have been certified as Top Employer for several consecutive years.
**How we will support you:**
Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status or any other characteristic protected by law. If you are living with disabilities, chronic illness, or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process.
**Locations**
Bray, Ireland
**Worker Type**
Employee
**Worker Sub-Type**
Apprentice / Trainee (Fixed Term) (Trainee)
**Time Type**
Full time
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Manager, Quality Control Projects

Sligo, Connacht AbbVie

Posted 5 days ago

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Job Description

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
We are looking for a QC Manager Projects to join our team on our Manorhamilton Road site in Sligo. The QC Manager Projects drives project-related activities within the QC department, focusing on the introduction of innovative analytical techniques, automation, and the transition to a paperless lab environment. This role is pivotal in the implementation of the "Lab of the Future" concept and managing lab expansion projects.
Responsibilities:
+ Lead and manage all project-related activities in the QC department.
+ Oversee the introduction of new analytical techniques, focusing on automation and paperless laboratory systems.
+ Manage the implementation of the Lab of the Future initiative in the QC department.
+ Coordinate and oversee laboratory expansion projects.
+ Manage and oversee compendial reviews, documentation control for QC, maintenance and calibration of analytical instrumentation, analytical work orders on maximo and retain management.
+ Manage purchasing and budget control, including vendor managed inventory, laboratory cleaning services and capital requirements for QC.
+ Manage and ensure delivery of training curricula for QC via laboratory trainer role.
+ Lead operational excellence in QC delivering on various initiatives including reduced testing program for QC.
+ Liaise with PDS&T to ensure execution of reference standard interval testing program.
+ Lead inspection readiness in QC. Participate in internal and external audits and address audit findings.
+ Ensure compliance with data integrity policies and regulatory requirements.
+ Liaise with cross-functional teams to facilitate project goals and timelines.
+ Present project updates and technical data to stakeholders effectively.
+ Report to the Senior QC Manager.
Qualifications
+ M.Sc./B.Sc. in Chemistry or a related discipline.
+ Experience working in API and OSD QC laboratories.
+ Minimum 4 years of experience in people management within a QC lab setting.
+ Strong project management, presentation, and communication skills.
+ Innovative thinking, with a commitment to advancing laboratory practices and compliance.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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