Quality Control Manager

Dublin, Leinster Amgen

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This job operates on a 16/5 cycle shift pattern. This job specification outlines the general responsibilities associated with the role of Manager QC Microbiology on the Amgen Manufacturing site. This role will be responsible for managing the QC Microbiology team and owning, facilitating, and undertaking activities pertaining to Microbiology within QC and Manufacturing. The successful candidate will focus on compliance, continuous improvement and implementing a lean culture and Right First Time (RFT) for QC Microbiology duties and testing, including release of commercial and global release testing. The role also represents the QC unit by liaising with internal and external stake holders.
The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role. This role will be responsible for oversight of some analytical in-process methods and may require shift work depending on company needs.
**Key Responsibilities:**
· Supervision/Management of QC Microbiology team.
· Ensure the QC Microbiology area is operated in a safe manner.
· Overall responsibility for QC In process, Environmental Monitoring, Release and Stability testing and the associated test and laboratory documentation.
· Develop and maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP Compliance with Standard Operating Procedures and Registered specifications.
· Provide an effective and efficient QC service to operations by supervising, developing and coaching the QC team.
· Ensure timely completion of Laboratory Investigation Reports and deviations through the Deviation procedures.
· Issue trend reports on investigations, non-conformances and Environmental Monitoring and identify laboratory practices and procedures for further development/improvement.
· Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.
· Approval of SOP's, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.
· Participate in regulatory agency inspections as required.
· Plan and implement procedures and systems to maximise operating efficiency.
· Manage and contribute to the achievements of department productivity and quality goals.
**Primary knowledge, skills, competencies and relevant experience Knowledge:**
Broad technical knowledge within Microbiology and expanding knowledge of related disciplinary areas Recognizes and understands the cross-dependencies of the role and understands the impacts on the organization Enhances own knowledge through understanding business trends and objectives Knowledge of industry and business principles Understands the core business process and purpose of the functional area in Amgen's commercialization process Developing own project management techniques
**Problem Solving** :
Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information Creates new procedures and processes to drive desired results Handles diverse scope of issues that require evaluation of a variety of factors including current business trends
**Autonomy:**
Managerial/Supervisory experience with a proven record in a Supervisor/ Team Lead role Experience leading cross-functional teams is desirable Work is guided by operational and project objectives Manages multiple assignments and processes Independently determines approach to project May be responsible for specific programs and/or projects Independently develops solutions that are thorough, practical, and consistent with functional objectives
**Contribution:**
Contributes to work group/team by ensuring quality of tasks/services provided by self and others with a strong focus on RFT and Lean Provides training and guidance to others Extends capabilities by working closely with senior staff/experts within and outside the internal organization
**Skills:**
Lead with initiatives to identify and drive improvements Communication skills (verbal and written) at all levels Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls) Presentation skills Escalate issues professionally and in a timely basis and know when to escalate Decision Making skills - will be require to make decisions independently Teamwork, Coaching and motivating others Negotiation and Influence skills, Planning and organisation skills Investigation skills Demonstrated ability to interact with regulatory agencies Experience working with interdepartmental and cross functional teams and influencing decisions
**Relevant experience:**
Bachelor's degree in a Science related field is required. 6+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, with 2 - 3 years of specific Microbiology management experience desirable. Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products. Some analytical experience for oversight of analytical in-process methods would be an advantage. Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating. Proven experience of leading teams.
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Quality Control Student

Dublin, Leinster Takeda Pharmaceuticals

Posted 1 day 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**
**_JOB PURPOSE:_**
The position will require a basic knowledge of analytical techniques, e.g. IR, UV, HPLC and GC. The position will require knowledge of GMP/GDP requirements and the principles of continuous improvement.
**_RESPONSIBILITIES_** **:**
**Quality Control Laboratory:**
+ Test laboratory samples including raw materials, packaging components, API, validation, stability and purified water.
+ Perform calibration activities and / or checks associated with QC equipment.
+ Ensure that the laboratory is kept clean, tidy and safe at all times and participate in the QC lab 5S program.
+ Participate in QC projects as required.
**General:**
+ Adhere fully to all company safety policies, procedures and regulations and work with others to promote a strong awareness of safety within the plant.
+ Participate fully in any cross functional training initiatives.
+ Drive and promote the corporate values of Takeda-ism within the workplace.
+ Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
+ Ensure timely completion of all SOP, reading, training and assessment.
+ Other duties as required and as directed by the Manager, Finance or other officer appointed by the Board of Directors.
+ Correct use of personal protective equipment (PPE)/garbing requirements.
**_EDUCATIONAL REQUIREMENTS:_**
+ **Studying towards 3rd Level Honours Degree in Science or other relevant course.**
**_RELEVANT EXPERIENCE/CRITERIA:_**
+ Technical experience in a wide range of analytical techniques e.g. wet chemistry, HPLC and GC analysis, particle size analysis.
+ Good organisational, communication, interpersonal and report writing skills.
+ Good computer skills and knowledge of the Microsoft Office suite of software.
+ Ability to adapt to changing priorities.
Ability to work within a team.
**Locations**
Grange Castle, Ireland
**Worker Type**
Employee
**Worker Sub-Type**
Paid Intern (Fixed Term) (Trainee)
**Time Type**
Full time
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Quality Control Officer

Dublin, Leinster Excel Recruitment

Posted 1 day ago

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Excel Recruitment is seeking a Quality Control Officer for our client who specialises in the fresh produce and food distribution industry. This is an exciting opportunity to join a company with a proud heritage and a strong commitment to quality, innovation, and customer service. Job description Key Responsibilities and Duties Approve incoming materials by confirming specifications, conducting a visual and measurement test, and rejecting and returning unacceptable materials. Approve all finished products by confirming specifications and conducting required tests. Completion of daily records/ traceabilities Ensuring food safety is maintained throughout the process in accordance with BRC and Bord Bia standards. A lot of walking / standing / checking of products in different areas of the packhouse such as Goods-In, Packhouse & Goods-Out Qualifications/Experience Level 7 in food science or similar qualification. Experience in a quality role is desired but not essential. Key Behaviours Excellent attention to detail Excellent communication skills Ability to work on own initiative If you or anyone you know would be interested in this role, please apply with your CV or contact Ciaran #INDUST Skills: quality control officer quality control officer
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Quality control officer

Dublin, Leinster Excel Recruitment

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permanent
Excel Recruitment is seeking a Quality Control Officer for our client who specialises in the fresh produce and food distribution industry.

This is an exciting opportunity to join a company with a proud heritage and a strong commitment to quality, innovation, and customer service.

Job description Key Responsibilities and Duties Approve incoming materials by confirming specifications, conducting a visual and measurement test, and rejecting and returning unacceptable materials.

Approve all finished products by confirming specifications and conducting required tests.

Completion of daily records/ traceabilities Ensuring food safety is maintained throughout the process in accordance with BRC and Bord Bia standards.

A lot of walking / standing / checking of products in different areas of the packhouse such as Goods-In, Packhouse & Goods-Out Qualifications/Experience Level 7 in food science or similar qualification.

Experience in a quality role is desired but not essential.

Key Behaviours Excellent attention to detail Excellent communication skills Ability to work on own initiative If you or anyone you know would be interested in this role, please apply with your CV or contact Ciaran #INDUST Skills: quality control officer quality control officer
This advertiser has chosen not to accept applicants from your region.

Quality control officer

Dublin, Leinster Excel Recruitment

Posted today

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Job Description

permanent
Excel Recruitment is seeking a Quality Control Officer for our client who specialises in the fresh produce and food distribution industry. This is an exciting opportunity to join a company with a proud heritage and a strong commitment to quality, innovation, and customer service. Job description Key Responsibilities and Duties Approve incoming materials by confirming specifications, conducting a visual and measurement test, and rejecting and returning unacceptable materials. Approve all finished products by confirming specifications and conducting required tests. Completion of daily records/ traceabilities Ensuring food safety is maintained throughout the process in accordance with BRC and Bord Bia standards. A lot of walking / standing / checking of products in different areas of the packhouse such as Goods-In, Packhouse & Goods-Out Qualifications/Experience Level 7 in food science or similar qualification. Experience in a quality role is desired but not essential. Key Behaviours Excellent attention to detail Excellent communication skills Ability to work on own initiative If you or anyone you know would be interested in this role, please apply with your CV or contact Ciaran #INDUST Skills: quality control officer quality control officer
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Quality Control Chemistry Manager

Dublin, Leinster Grifols Shared Services North America, Inc

Posted 4 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.
At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
We're excited to invite you to lead our Quality Control (QC) Chemistry Laboratory team in our purification and aseptic filling facility at Grifols Worldwide Operations (GWWO). As **QC Chemistry Manager** , you will play a key role in ensuring high-quality laboratory testing of clean utility, raw material, in-process and final container materials, maintaining full compliance with current Good Manufacturing Practices (cGMP) and safety standards.
**Key Responsibilities:**
- Management of the QC Chemistry team to carry out required chemistry, immunochemistry and protein testing as required
- Ensure QC testing of clean utility, raw material, in-process and final container testing is performed as per the production plan
- Manage integrity of Laboratory Data
- Ensure all methods are qualified/validated in line with site procedures and regulatory/compendial requirements
- Ensure all equipment is validated, maintained, calibrated, and requalified in line with site procedures and regulatory/compendial requirements
- Creation, review and update of test methods and SOPs to ensure all aspects of compliance are adhered to
- Drive and oversee process/product/OOS/deviation investigations
- Implementation of Corrective and Preventative Actions
- Maintain, monitor and report QC Chemistry metrics and KPIs
- Ensure training and development of QC Chemistry team members in conjunction with team development and goals via the performance management process
- Represent QC Chemistry in any regulatory, corporate or internal audits
- Ensure regular Quality interaction with other departments within GWWO and Grifols sister sites
- Support site quality activities, including but not limited to: Annual Product Quality Reviews (APQRs), recall activities, change control etc.
- Responsible for any projects impacting QC Chemistry such as Method Transfers, Process Improvement or Harmonisation Projects
- Keep Abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities
- Manage the safety and performance of QC Chemistry in line with safety regulations and site procedures
- Perform additional duties as assigned
- Act as a delegate for activities performed by the QC Senior Manager for QC Chemistry activities
**Knowledge & Skills:**
- Full understanding of relevant cGMP, quality and compliance regulations
- Experience with chromatography instrumentation and methods
- Experience with protein chemistry instrumentation and methods
- Method Transfer and qualification experience
- Understanding of pharmacopoeial requirements and methods
- Excellent communication skills at organisation, team and individual levels
- Demonstrated problem solving skills
- Strong decision making skills
- Strong presentation skills
- Ability to manage multiple projects to plan/budget
- Experience in developing analytical methods is desirable
- Experience with Statistical Process Control (SPC) is desirable
- Experience with Lab Management Systems & SAP is desirable
**Qualifications:**
- BSc or equivalent in chemistry, biochemistry, pharmaceutical science or related field
- Minimum 3 years supervisory/management experience
- 8 years progressive experience as an individual contributor in a fast paced GMP Laboratory environment
- M.Sc. qualification is desirable but not essential
**Our Benefits Include:**
+ Highly competitive salary
+ Group pension scheme - Contribution rates up to 7%
+ Private Medical Insurance for the employee
+ Ongoing opportunities for career development in a rapidly expanding work environment
+ Succession planning and internal promotions
+ Education allowance
+ Wellness activities - Social activities eg. Golf, Padel, Summer Events
We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply - we're excited to hear from you.
#LI-FD1
**Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3 ( more about Grifols
**Req ID:**
**Type:** Regular Full-Time
**Job Category:**
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Senior Associate Quality Control (Shift)

Dublin, Leinster Life Science Recruitment Ltd

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Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Senior Associate QC will work under minimal supervision, responsible for one or more of the following activities in QC including analytical testing in process, stability, and finished products. In-depth HPLC experience with Empower Software, some protein concentration testing background with strong GMP lab environment experience. Duties: Testing of in process, stability and finished product samples. eg HPLC, CE, SDS-PAGE, IEF analytical testing, characterization and sample and data management. Review and authorisation of Lab Data Support Analytical Technical Transfer activity testing reports and documentation. Document review/updates when required. Equipment Calibration, Maintenance and Trouble Shooting. Method Validation/Verification. Training of QC Chemistry Laboratory colleagues. Laboratory Investigation support Laboratory Housekeeping and maintaining GMP standards. Assisting in regulatory audits. Education and Experience: Hold a third level qualification (Degree/Diploma) in Biochemistry, Chemistry, Biology Biotechnology or similar Scientific Subject. 5+ years relevant experience in a pharmaceutical/healthcare environment. Have strong technical writing skills. Be detail oriented, self-motivated with good troubleshooting and problem solving abilities. Experience with analytical techniques such as HPLC, CE, SDS-PAGE, IEF testing would also be advantageous. If interested in this posting please feel free to contact Avishek Singh at Avishek.sing or for further information.
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Senior associate quality control (shift)

Dublin, Leinster Life Science Recruitment Ltd

Posted today

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Job Description

permanent
Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin.

This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Senior Associate QC will work under minimal supervision, responsible for one or more of the following activities in QC including analytical testing in process, stability, and finished products.

In-depth HPLC experience with Empower Software, some protein concentration testing background with strong GMP lab environment experience.

Duties: Testing of in process, stability and finished product samples.

eg HPLC, CE, SDS-PAGE, IEF analytical testing, characterization and sample and data management.

Review and authorisation of Lab Data Support Analytical Technical Transfer activity testing reports and documentation.

Document review/updates when required.

Equipment Calibration, Maintenance and Trouble Shooting.

Method Validation/Verification.

Training of QC Chemistry Laboratory colleagues.

Laboratory Investigation support Laboratory Housekeeping and maintaining GMP standards.

Assisting in regulatory audits.

Education and Experience: Hold a third level qualification (Degree/Diploma) in Biochemistry, Chemistry, Biology Biotechnology or similar Scientific Subject.

5+ years relevant experience in a pharmaceutical/healthcare environment.

Have strong technical writing skills.

Be detail oriented, self-motivated with good troubleshooting and problem solving abilities.

Experience with analytical techniques such as HPLC, CE, SDS-PAGE, IEF testing would also be advantageous.

If interested in this posting please feel free to contact Avishek Singh at Avishek.sing or for further information.
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Quality assurance inspector, (Plumbing) - Dublin

Dublin, Leinster Design Build Search

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Design Build Search are working closely with a leading Energy specialist who continue to expand nationwide. Due to securing a large framework they have an opening for a field based quality assurance inspector. The successful applicant will be responsible for reviewing and assessing works installed by registered contractors into the homes of scheme applicants throughout the country. This position will require travel with overnight stays required average 1 night per week. These inspections are designed to ensure that works installed under these grant-based scheme conform to the high-quality specifications expected. Requirements: FETAC Level Six qualification in plumbing. Strong knowledge and experience of construction. RGII Qualified (preferable). Heat Pump Installer Course (preferable). Knowledge of insulation measures/techniques (preferable). Pleasant, friendly manner with an ability to work well in a team environment. Reasonable computer knowledge/technological skills. Good verbal and written communication skills. An ability to understand, capture and interpret customer information. Good powers of judgement and an ability to manage challenging customer interactions An ability to adapt to the changing demands of the KSN Energy/SEAI strategy. Quality management; looking for means of improving as well as promoting quality. Key Roles and Responsibilities: The carrying out of Inspections on properties after works have been completed on the Better Energy Schemes. The inspections must be carried out in accordance with the SEAIs Code of Practice and Standards and Specifications. The accurate completion of all inspection documentation; whether on paper or electronic device. The provision of energy advice/guidance to applicants, colleagues, and registered contractors on the scheme. Provide customer service in line with the agreed code of practice and quality standards. Manage and fulfil appointments made with homeowners through our helpdesk. Conduct follow up activities and administration duties which may include outbound calls, emails, and paperwork. Attend training courses as necessary. Attend to any other reasonable request as instructed by scheme management. ability to work well in a team environment. Reasonable computer knowledge/technological skills. Good verbal and written communication skills. An ability to understand, capture and interpret customer information. Good powers of judgement and an ability to manage challenging customer interactions An ability to adapt to the changing demands of the KSN Energy/SEAI strategy. Quality management; looking for means of improving as well as promoting quality. Whats on offer? Fully expensed company vehicle Starting salary €60k per annum Food Allowance Career development, CPD courses & professional memberships Tools, equipment, and uniform provided 20 days annual leave plus company days, bank/public holidays Bonus & incentive schemes Mental Wellbeing Support Programme Employee Tax Saver Schemes, including Bike to Work Regular social events and team support Skills: Quality inspector Plumbing Construction Engineering managemen energy
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Quality assurance inspector, (plumbing) - dublin

Dublin, Leinster Design Build Search

Posted today

Job Viewed

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Job Description

permanent
Design Build Search are working closely with a leading Energy specialist who continue to expand nationwide.

Due to securing a large framework they have an opening for a field based quality assurance inspector.

The successful applicant will be responsible for reviewing and assessing works installed by registered contractors into the homes of scheme applicants throughout the country.

This position will require travel with overnight stays required average 1 night per week.

These inspections are designed to ensure that works installed under these grant-based scheme conform to the high-quality specifications expected.

Requirements: FETAC Level Six qualification in plumbing.

Strong knowledge and experience of construction.

RGII Qualified (preferable).

Heat Pump Installer Course (preferable).

Knowledge of insulation measures/techniques (preferable).

Pleasant, friendly manner with an ability to work well in a team environment.

Reasonable computer knowledge/technological skills.

Good verbal and written communication skills.

An ability to understand, capture and interpret customer information.

Good powers of judgement and an ability to manage challenging customer interactions An ability to adapt to the changing demands of the KSN Energy/SEAI strategy.

Quality management; looking for means of improving as well as promoting quality.

Key Roles and Responsibilities: The carrying out of Inspections on properties after works have been completed on the Better Energy Schemes.

The inspections must be carried out in accordance with the SEAIs Code of Practice and Standards and Specifications.

The accurate completion of all inspection documentation; whether on paper or electronic device.

The provision of energy advice/guidance to applicants, colleagues, and registered contractors on the scheme.

Provide customer service in line with the agreed code of practice and quality standards.

Manage and fulfil appointments made with homeowners through our helpdesk.

Conduct follow up activities and administration duties which may include outbound calls, emails, and paperwork.

Attend training courses as necessary.

Attend to any other reasonable request as instructed by scheme management.

ability to work well in a team environment.

Reasonable computer knowledge/technological skills.

Good verbal and written communication skills.

An ability to understand, capture and interpret customer information.

Good powers of judgement and an ability to manage challenging customer interactions An ability to adapt to the changing demands of the KSN Energy/SEAI strategy.

Quality management; looking for means of improving as well as promoting quality.

Whats on offer? Fully expensed company vehicle Starting salary €60k per annum Food Allowance Career development, CPD courses & professional memberships Tools, equipment, and uniform provided 20 days annual leave plus company days, bank/public holidays Bonus & incentive schemes Mental Wellbeing Support Programme Employee Tax Saver Schemes, including Bike to Work Regular social events and team support Skills: Quality inspector Plumbing Construction Engineering managemen energy
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