93 Process Technologist jobs in Ireland
Quality Control
Posted today
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Job Description
We are looking for a dedicated Administrator who would be a key member of the company leadership team, responsible for ensuring that the service we provide is safe and compliant with all industry and certification regulations.
The candidate should have a "can-do" attitude that drives effective change and moves the company processes positively which will effectively lead to the provision of an optimum service to our clients.
We seek an effective coach and communicator who can skillfully create an empowered and engaged workforce culture.
The candidate should have knowledge of construction safety, quality and continuous improvement via effective data analysis and decision-making.
Key Responsibilities:
· Assure that all stakeholders are well trained in support of the I.M.S
· Manage and supervise I.M.S. administration and site activities
· Ongoing auditing to promote compliance with I.M.S. and H&S procedures
· Use effective negotiation skills to drive alignment and resolve conflict
· Provide coaching and constructive feedback
· Collaborate with team and cross-functional stakeholders
· Evaluate data, assess and develop ongoing improvements to the company I.M.S. and H&S procedures
Requirements:
· 3+ years of experience in quality management / Health & Safety
· Experience in business administration will be an advantage.
· In-depth knowledge of health & safety /quality control procedures and legal standards.
· Strong attention to detail, organisational, and leadership skills.
· Strong knowledge of data analysis, and statistical methods.
· Excellent communication and listening skills.
· Formal training in H&S and environmental monitoring and auditing will be an advantage
Job Types: Full-time, Permanent
Pay: €40,000.00-€50,000.00 per year
Benefits:
- Company pension
- On-site parking
Work Location: In person
Quality Control Specialist
Posted today
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Job Description
Job Description
We have a great opportunity for a Quality Control Specialist to join our Carlow site. You will join a self-directed team and provide trouble shooting support. The quality control specialist will have the opportunity to be involved in and lead various exciting projects.
What you will do
Bring energy, knowledge, innovation and leadership to carry out the following
- Support new product introductions and provide quality expertise during product release.
- Generate, review, approve, and expedite QC GMP documentation, including Quality Notifications, Laboratory Investigations, CAPAs, Effectiveness Checks, SOPs, SWIs, change controls, Annual Product Reviews, Trend Reports, Out of Process Control Limit (OOPCL) events, and Compendial Assessments.
- Develop, revise, and roll out operational procedures and training materials.
- Lead and support batch release activities by completing timely investigations, quality notifications, OOPCL events, and generating interim/summary reports.
- Raise and investigate CAPAs and quality notifications using standard problem-solving tools (FMEA, Fishbone diagrams, 5 Whys), and implement corrective actions via change management.
- Provide coaching, mentoring, and guidance to lab teams
- Act as a document system expert review, approve, format, and facilitate documentation workflows.
- Lead or support projects and promote teamwork, open communication, and a high-performing, inclusive culture.
- Collaborate cross-functionally to ensure manufacturing, testing, and release processes comply with cGMP and regulatory standards.
- Support qualification/validation, technical transfers, and commercial operations with quality oversight.
- Perform laboratory testing and material inspections according to approved methods, including analytical, microbiological, environmental monitoring, and stability testing.
- Detect, report, investigate, and close out out-of-specification (OOS) and out-of-trend (OOT) results.
- Manage and monitor Quality Management Systems, generate performance and quality event reports.
- Provide quality support for supplier/material qualification, validation, risk management, and quality agreements.
Lab operates on a two-shift cycle pattern (7am-3pm/3pm-11pm)
In order to excel in this role, you will more than likely have
- Bachelor's degree or higher in Analytical Chemistry, Biochemistry, Biology, or a related discipline preferred.
- 5+ years' experience in a pharmaceutical laboratory, ideally in a similar role.
- Excellent troubleshooting, analytical, and problem-solving skills.
- Strong technical knowledge and scientific qualification relevant to the pharmaceutical environment.
- Strong experience with HPLC systems, bioassay methods, and associated software is desirable.
- Experience with cGMP, GLP, Quality Management Systems, method validation, and method transfer.
- Proficient in QC systems such as EN, LIMS, Trackwise, and Microsoft Office.
- Knowledge of Irish, European, and international regulatory codes and standards.
- Effective verbal and written communication skills with strong influencing capability.
- Commitment to maintaining a safe, compliant, and quality-focused culture.
As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
So, if you are ready to
Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world's leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.
Required Skills
Accountability, Accountability, Adaptability, Analytical Chemistry, Analytical Instrumentation, Analytical Method Development, Batch Releases, Biochemistry, Corrective Action Management, Data Integrity, Dissolution Testing, Driving Continuous Improvement, GMP Compliance, Ishikawa Diagrams, Karl Fischer Titrations, Laboratory Documentation, Laboratory Safety, Laboratory Testing, Management Process, Microbiological Analysis, Microbiological Test, Microsoft Office, Quality Control Management, Quality Management System Auditing, Quality Management System Improvement {+ 4 more}
Preferred Skills
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status
Regular
Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Not Applicable
Shift
Valid Driving License
Hazardous Material(s)
Job Posting End Date
10/17/2025
- A job posting is effective until PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID
R
Quality Control Engineer
Posted today
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Job Description
Overview:
The Engineer is responsible for setting out the site and applying dimensional controls in line with drawings, specifications and surveys. The role ensures that tolerances are met without loss of quality or space and supports efficient sequencing of works. The Engineer provides technical advice, monitors quality and assists the project team in line with company procedures and the Sisk Safety Statement.
John Sisk & Son have been building excellence as a family-owned international construction company by offering trust, certainty and value to our clients whilst being at the heart of change.
Responsibilities:
- Set out works in line with drawings, specifications and site surveys
- Liaise with planners to align programmes and supplier outputs
- Check materials and works in progress for compliance with specifications and quality standards
- Contribute to Inspection and Test Plans and ensure supply chain provides required test data
- Raise and resolve RFIs with client representatives, suppliers, subcontractors and statutory bodies
- Maintain quality control and records in line with method statements, quality plans and inspection procedures
Review subcontractor drawings and ensure correct use of contract records and specifications
Ensure purchase orders define technical requirements accurately
- Strong interpersonal and communication skills with ability to influence and work with senior management
- Ability to analyse, evaluate and adapt approach to project needs
- Experience across a range of trades including piling, geotechnical, substructures, superstructures and facades
- Competence in BIM and ability to work with 3D scanning or point cloud data an advantage
- Articulate and numerate with ability to produce objective and persuasive reports
- Demonstrates initiative, resilience and problem-solving ability
Experience:
- Experienced Engineer able to direct a team, and others that do not report directly.
- Have a good knowledge of construction processes and standards.
- Computer literate.
- Must be able to evaluate information to assess compliance with requirements and identify improvement opportunities. This should include the ability to analysis data to identify trends.
- Organisational skills and workload prioritising.
- Good interpersonal skills
- Ability to work independently and use initiative.
- Ability to work as part of a team.
- A commitment to identify, develop, direct and implement key objectives
- Able to deal with staff, clients, and external customers.
- Supervise and mentor junior or trainee engineers
- Provide input into measurement and valuation with the project quantity surveyor
- Maintain site diaries and prepare reports
- Carry out pre-start condition surveys
- Manage and record delivered materials including concrete, reinforcement and structural products
- Assist with installation of site facilities such as hoardings and accommodation
- Carry out snagging and de-snagging before handover
- Support safe working practices including reviewing subcontractor safety plans and preparing method statements
- Actively develop own skills and mentor others through knowledge sharing
Qualifications:
Required
- Degree or Diploma in Engineering
- SMSTS or MSIC certification
- First Aid training
- Lifting Supervisor certification
- Temporary Works Coordinator training
- Chartered or working towards professional membership with Engineers Ireland or the Institution of Civil Engineers
Desirable
- Project Management qualification
- Training in planning software
- Current full driving licence
Additional Information:
- Competitive Salary with yearly increase
- 26 days holiday (option to purchase 5 more)
- Company Car or Car allowance
- Employer pension
- Competitive mileage rate
- Travel expenses
- Flexible and remote working
- Enhanced parental leave
- Professional and Educational development
Our people are at the heart of our success and our proposition to them is work with purpose, have time for life, build a career with no limits and surround yourself with great people.
Our Internal Recruitment Team fulfil all vacancies on a direct basis. Unsolicited contact by unapproved agencies (sharing speculative CVs) will not be accepted and introductory fees will not apply.
Sisk Group is an equal opportunities employer. We welcome applications from all qualified candidates, regardless of gender, race, ethnicity, disability, age, sexual orientation, religion, or any other protected characteristic. We are committed to fostering an inclusive workplace and will provide reasonable adjustments during the recruitment process where required.
This role profile and all associated recruitment materials have been prepared in line with current and emerging legal and regulatory requirements, including the EU Pay Transparency Directive and the Equality Acts (UK & Ireland). All language is gender-neutral and inclusive, and the requirements listed are based solely on objective role performance needs. Sisk Group is committed to ensuring fairness, transparency, and compliance in all recruitment and employment practices.
At Sisk we are committed to attracting and hiring diverse talent into our organisation. We know the confidence gap and imposter phenomenon can get in the way of meeting remarkable candidates. We also know that candidates from underrepresented backgrounds often don't apply for roles if they don't feel they meet all the criteria. Give your transferable skills the chance to tell the full story. It's not all about your technical expertise. Don't hold back, we'd love to hear from you.
Quality Control Manager
Posted today
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Cairn has a unique opportunity for a Quality Manager who will play a key role within the Quality team reporting directly to the Quality Lead. They will liaise with their respective site, quality teams to advocate, promote and ensure that Quality is embedded across all sites.
Responsibilities:
- Support Quality lead with assigned certifier and Industry quality knowledge
- Coordinate, prepare and Lead in the Rollout of Procore Quality DMS platform
- Coordination of updates on Current DMS systems Quality forms and processes, with regular meetings with DMS team
- Undertake Regular reviews of Carin Quality Processes and Procedures in particular.
- Robust Benchmarking processes
- Alignment of Quality processes with current and future BCAR requirements
- Compliance with Partner/ client requirements including contractual obligations
- Review of comparable industry processes
- Attend Benchmarking inspections on site
- Independent Inhouse audit of current projects
- Product compatibility
- Product Applications and Suitability
- Product Robustness
- Identifying and issuing Quality memos and alerts as agreed with the Quality Lead
- Coordinate with Technical managers
- specifying correct products / performance criteria
- Tech Sub Approvals
- Forward look towards Homebond / LDI / Passive House / Purchaser requirements and business protection
- Undertake a schedule of inhouse training to Technical, Construction, Operational, Customer and Aftercare departments, including;
- BCAR Processes and awareness
- Facades and Fire Safety
- Assigned Certifier awareness
- Quality Management during Construction
- Identifying strategic training requirements
- Co-ordinate the implementation of project quality processes and procedures with our project teams.
- Undertake reviews of our Integrated Management system against our quality policies and procedures to ensure conformity, work with quality lead on IMS improvements in line with business requirements
The Candidate;
- 10+ years' experience in a construction/ technical or quality role
- Previous technical experience in building surveying / inspection / engineering of quality standards
- Understanding of compliance and implementation of BCAR process
- Ability to evaluate and manipulate data
- Understanding of various material compliance and compatibility
- People management & stakeholder management exp
- Curious tenacity towards problem solving with a result-oriented mindset
- Ability to develop collaborative relationships with stakeholders internally and externally
- Takes accountability to challenge, question and drive toward resolution
- Clear verbal and written communication essential
Working with Cairn:
At Cairn, we believe it is essential that our employees feel valued and appreciated. We therefore offer above industry average remuneration packages with a comprehensive benefits portfolio that's ready to support you for whatever life brings.
We are delighted to offer a suite of benefits when you join Cairn which include;
- Competitive salary
- Performance related bonus
- Pension scheme with matching contributions
- Full health insurance with Irish Life health
- Annual salary review
- Continuous Professional development (CPD) programme & funding
- Paid maternity & paternity leave
- Free Cairn annual leave days
- Life assurance
- Income protection
- Employee Assistance Programme with VHI
- Tax saver - travel and bike to work
- Culture Committee
- Talent Development Programmes
- Approved Profit Sharing Scheme (APSS)
- Company vehicle (role dependent)
The Cairn purpose is to build sustainable communities where people can thrive.
At Cairn, it's not what we build, it's why we build. It's about putting down a marker that will stand for generations to come. Creating new communities of connection and belonging for an Ireland where people can thrive. Reshaping, redefining, reinvigorating our place in the world. Building for people, progress, and potential.
Because when Cairn build, it's Built For Good.
Quality Control Analyst
Posted today
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Job Description
My client is seeking to recruit a QC Material Management Analyst to join the QC Site Operations team at their Multi-Product Cell Culture Drug Substance Facility in Dublin.
Reporting to the QC Material Management Supervisor, you will be responsible for supporting site activities related to performing testing of Raw Materials, in-process samples, and laboratory duties in accordance with cGMP regulations.
Key responsibilities include:
- Performing QC testing (TOC, pH Conductivity) of water samples, and analysis of Raw Materials including HPLC, KF, UV, IR, and wet chemistry techniques. Completing laboratory documentation in a timely and accurate manner as directed.
- Ensuring compliance with Standard Operating Procedures and Registered Specifications.
- Assisting in authoring and reviewing documentation, including SOPs, as required.
- Reviewing batch paperwork and reconciling analyses performed in the laboratory, ensuring any out-of-specification results are investigated according to procedures.
- Supporting technical transfer of new projects.
- Assisting with out-of-specification investigations and deviations using the Infinity system.
- Performing sample management activities and ensuring chain of custody is maintained using CIMS and LIMS.
- Keeping up to date with current industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.
- Carrying out other activities as indicated by the Lab Supervisor.
Requirements:
- Third level qualification (Degree) in Chemistry, Biology, or related discipline.
- At least 2-3 years of experience in a pharmaceutical or healthcare laboratory or related technical function.
- Strong written and verbal communication skills, with the ability to work effectively in a collaborative team environment.
The Next Step for you:
Should this position be of interest to you please submit your CV to Barry O'Mahony from Next Generation Recruitment using the apply button.
Next Generation will never share your data outside of our organisation without your prior written consent. Please read our Data Protection Policy on our website. If you require any reasonable accommodations during the recruitment process please let us know and we will do our best to support you.
Quality Control Analyst
Posted today
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Job Description
PE Global is currently recruiting for a Senior QC Analyst for a leading multi-national Medical Devices client based in Galway.
This is a contract position.
Role:
- Act as Subject matter expert and provide oversight for critical NPD areas:
- Dissolution/Elution (USP APPII/USP APPVII)
- Liquid/Gas Chromatography
- Analytical test method development
- Analytical test method validation
- Work independently to plan and schedule activities to meet project timelines
- · Author technical reports and validation documents
- · Provide guidance and communicate updates to cross-functional and cross-site teams
- · Support laboratory investigations to determine root cause and implement meaningful corrective actions
- · Drive continuous improvement projects to reduce testing lead-times and support cost saving targets
- · Supports Training of new colleagues
- · Supports Internal and External Audit programs
- Support Regulatory submissions
Requirements
• Bachelors degree in a science discipline
• 3-5 years experience in Medical Devices or related Industry
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up to date CV to
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
Quality Control Microbiologist
Posted today
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Job Description
Are you passionate about microbiology and quality control in a fast-paced pharmaceutical environment?
We're looking for a
QC Microbiology Analyst
to join our Client on there site in Blanchardstown, Dublin. This is a
lab-based role
, offering the chance to make a real impact on patient safety and product quality.
About the Role
As a QC Microbiology Analyst, you'll play a vital role in ensuring our products meet the highest regulatory and quality standards. You'll carry out microbiological testing, support manufacturing operations, and contribute to continuous improvement initiatives across the site.
Key responsibilities include:
- Performing microbiological testing such as:
- Environmental monitoring
- Water sampling & testing
- Bioburden & endotoxin testing
- Growth promotion testing of media and diluents
- In-process testing & compendial verifications
- Data analysis, trending, and timely reporting of results
- Supporting method validation, verification, and transfer activities
- Liaising with cross-functional teams to ensure testing schedules are met
- Oversight of contract testing laboratories (sample shipping, reconciliation, trending)
- Preparing for and supporting internal and external audits (HPRA, FDA, Corporate)
- Driving safety, compliance, and continuous improvement initiatives
What We're Looking For
- Education:
Minimum BSc in Science (or equivalent Level 7 Laboratory Apprentice qualification) - Experience:
At least 2 years in a QC role, ideally within pharmaceuticals - Strong background in bioburden, endotoxin, and environmental monitoring (preferred)
- Experience with method validation/development (advantageous)
- Excellent problem-solving, decision-making, and communication skills
- Ability to work effectively in a team and manage priorities in a fast-paced environment
- Proficiency in Microsoft Office and technical documentation
- High levels of integrity, accuracy, and attention to detail
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Quality Control Microbiologist
Posted today
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The role:
PE Global is currently recruiting for a QC Microbiology Analyst on behalf of a leading pharmaceutical company based in Dundalk. This is an initial 11-month contract role.
Shift :
Please note this role will start on days to get trained up and move to shift 7-7 days only. 4 on 4 off.
Shift Pattern: For days it will be Monday – Friday. For shift the Pattern is: 4 Days On/ 4 Days Off. 12 Hour days. Shift Premium: 20%
The QC Microbiology Analyst role is a critically important activity, ensuring efficient and effective compliant design, construction, qualification, and operation of the new strategic Biotech Drug Substance facility in Swords. This position will be responsible for qualifying the Microbiology Quality Control lab and the transfer of Microbiological analytical methods including but not limited to cutting edge Rapid Microbiological Methods.
This person will be key in the layout of the lab testing flow to ensure the process is streamlined and in line with lean principles. Additional development opportunities within the micro and chemistry lab will be strongly considered to recognize the tremendous value of knowledge / experience gained by the candidate during the project phases.
Role Functions
(Functions include, but are not limited to, the following)
- The motivation to be an inspiring member of a high performing team.
- The desire to continuously learn, improve and develop.
- Perform supporting activities for general lab readiness, laboratory equipment qualification and method transfers.
- Perform and carry out a variety of routine microbiological analytical techniques including but not limited to environmental monitoring, WFI testing, growth promotion testing, In-process product testing, Final product testing such as bioburden and both Kinetic turbidmetric and MCS rapid endotoxin testing in compliance with GMP requirements.
- To integrate and complete all documentation on time and be familiar with LIMS.
- To train and be trained in the use of Rapid microbiology techniques including but not limited to endotoxin testing, water bioburden testing, EM testing, absence of bioburden testing and identification testing.
- Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations and industry standards.
- To update SOP's and write protocols as required.
- Support the laboratory testing schedule to achieve an efficient QC system.
- Receive and manage samples that come into the lab for stability, in-process and release testing.
- Reagent preparation, cleaning, and routine equipment maintenance.
- Maintain good housekeeping and GLP within the laboratory.
- Calibrate and maintain all designated laboratory instruments.
- Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
- Ensure training is current for all job functions performed.
- Assist in training new QC Analysts on routine procedures and practices.
- Order, stock and receive laboratory supplies.
- Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
- Ensure that cGMP standards are maintained at all times.
- Delivery of area performance to meet or exceed performance or quality goals.
- Promote and participate in the implementation and maintenance of the relevant safety programmes.
- Participate and Comply with the Quality Management System requirements.
- Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools.
- This position will be on days initially but shift work will be required.
Experience, Knowledge & Skills
- 1 to 2 years' relevant experience.
- Experience and critical skills in the area of expertise that add value to the business; ideally analytical microbiology, in a GMP setting.
- Knowledge of cGMP.
- Report, standards, policy writing skills required.
- Lean Six Sigma Methodology experience.
- Understand the specific responsibilities of all departments as they relate to one's own department, understanding the business processes one's department supports.
- Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
Qualifications & Education
- Third Level science qualification (Microbiology is preferred).
To maximize the development opportunity, the candidate will be the key talent in analytical Microbiology techniques and in current Pharmacopeial methods.
The facility will utilize the latest innovations in technology and automation to. The candidate will work with a high performing cross functional team of talent sourced from across the biotechnology industry. Together, the team will build the future of Biotech through a Quality culture that delivers unconstrained supply, Right First Time to our patients through an inspired team.
The candidate will be actively supported and encouraged to continue their development and knowledge build, incorporating areas to support their future development and ability to continuously improve in their current role.
The candidate will provide support to other analysts within the lab area, including training and guidance on their area of expertise.
The full analytical scope of QC will incorporate microbiology, mycoplasma (DNA) analytics, analystical chemistry, bioassay, raw materials, stability and in-process testing. Advanced analytical methods (rapid ID techniques, paperless lab, etc) will allow the successful candidate to work in a innovative and stimulating environment which encourages communication and ideas for the future. The candidate will have responsibilities in analytical transfer and qualification of methods.
Interested candidates should submit an updated CV.
Please click the link below to apply, alternatively send an up to date CV to
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
Quality Control Microbiologist
Posted today
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Job Description
Role:
QC Microbiologist
Location:
Fully on site in Dundalk, Ireland
Contract:
Until June 2026 (with possibility of extension)- Full-time, 39 hours weekly
Company:
A Global Pharmaceutical Company
Role Overview:
Reporting to the Microbiology Lead, this role provides real-time QC oversight for Drug Substance/Drug Product manufacturing. It is a key position within Quality, directly supporting daily manufacturing activities to ensure compliance with cGMP and corporate/local SOPs.
Key responsibilities
- Provide QC support for technology transfer and commercial manufacturing operations.
- Review SOPs, risk assessments, change controls, and related documentation for DS/DP operations.
- Lead/participate in microbiology projects: microbial method validation and testing, environmental monitoring, organism identification, facility qualification, cleaning validation, and process validation.
- Perform microbial testing; support atypical/OOS investigations; drive/track change controls and CAPAs.
- Monitor and trend method performance with supervisors and cross-functional partners.
- Author technical documents: methods, protocols, validation/qualification plans and reports, SOPs.
- Offer technical guidance and assess/introduce new microbiology technologies.
- Support the Microbiology Lead in developing microbial control strategies, quality enhancements, and operational efficiency improvements.
- Communicate effectively and take a lead role in project management interactions with internal and external stakeholders (e.g., Quality Assurance, Regulatory Affairs, Analytical Development, clients).
- Serve as a primary point of contact for project coordination, including emails and client meetings.
- Prepare for and participate in regulatory inspections (e.g., FDA, EMA) and client/internal cGMP audits.
- Perform all tasks in compliance with applicable regulations, international standards, and company policies and SOPs.
- Other duties as assigned.
Education
- BSc in Microbiology or a related discipline.
- 1–3 years of relevant industry experience.
Work experience
- Experience in a highly regulated environment.
- Ability to interpret technical documentation.
- Working knowledge of cGxP requirements and regulations.
- Practical problem-solving skills, including formal root-cause tools (e.g., Ishikawa, FMEA).
Professional knowledge
- Microbiological testing and peer review.
- GMP compliance and inspection readiness.
Quality Control Lead
Posted today
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Job Description
Job Title: QC Team Leader Phoenix Healthcare
Department:
Quality Control
Reports To:
QC Manager
Location: Phoenix Healthcare
Unit 31, Second Ave, Cookstown, Dublin, D24 TP60, Ireland.
Contract Type:
Full-Time / Permanent (on-site)
Job Purpose
To lead and supervise the day-to-day operations of the Quality Control (QC) laboratory at Phoenix Healthcare. The QC Team Leader is responsible for ensuring all testing activities are conducted to the highest GMP and regulatory standards, providing leadership to QC Analysts, and supporting the QC Manager in maintaining an efficient, compliant, and audit-ready laboratory.
Key Duties and Responsibilities:
Leadership & Team Development
- Supervise, lead, and mentor QC Analysts to ensure competency, efficiency, and compliance.
- Allocate workloads and manage daily priorities to meet testing timelines.
- Conduct training, competency assessments, and staff performance reviews.
- Support the development of a high-performing, motivated QC team.
Operational Responsibilities
- Oversee QC testing of raw materials, intermediates, finished products, and stability samples.
- Ensure laboratory testing is performed according to SOPs, pharmacopeial methods, and regulatory standards.
- Review and approve analytical data, reports, and logbooks.
- Ensure equipment qualification, calibration, and maintenance activities are performed on time.
- Support method validation, transfer, and troubleshooting.
Compliance & Quality
- Ensure QC operations comply with GMP, GLP, HPRA, MHRA, FDA, and other regulatory requirements.
- Maintain full adherence to Phoenix Healthcare SOPs, Quality Management System (QMS), and Data Integrity standards.
- Lead and support investigations (OOS, OOT, deviations, CAPA, change controls).
- Ensure audit readiness and actively participate in regulatory/customer audits.
- Promote continuous improvement within the laboratory.
Documentation & Reporting
- Ensure accurate and timely completion of laboratory records and test documentation.
- Provide updates, reports, and KPIs to the QC Manager.
- Contribute to Annual Product Quality Reviews (APQRs) and trending of stability data.
Cross-Functional Collaboration
- Liaise with QA, Production and Regulatory teams to resolve testing or compliance issues.
- Act as Deputy QC Manager when required.
Person Specification
Qualifications
- Degree in Chemistry, Pharmaceutical Sciences, or related discipline (BSc/MSc).
Experience
- Minimum 5 years' QC experience within pharmaceutical/healthcare industry.
- At least 2 years' supervisory or leadership experience.
- Strong knowledge of GMP, ICH guidelines, and pharmacopeial methods.
- Experience with HPLC, GC, UV, FTIR, dissolution, and other analytical techniques.
- Experience of audits (HPRA/MHRA/FDA/customer) desirable.
Skills & Competencies
- Strong leadership and people management skills.
- Excellent communication and interpersonal skills.
- High attention to detail and focus on compliance/data integrity.
- Effective problem-solving and decision-making skills.
- Ability to manage priorities and work under pressure.
Key Performance Indicators (KPIs)
- On-time completion of QC testing and batch release support.
- Compliance with GMP and Data Integrity requirements.
- Effective management and development of QC staff.
- Minimal audit observations relating to QC operations.
- Delivery of continuous improvement initiatives.