77 Sterility Assurance Specialist jobs in Ireland

LSC have a great opportunity for a Senior QA Specialist to join a South Dublin-based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. If you have 7+ years of experience in construction management/engineering within the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect project for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products Quality review and approval of Process Development and Validation documentation Technical transfer documents Validation Protocols, executed validation documents and reports Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records ABOUT YOU - ARE YOUR SKILLS A MATCH? Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G visa or a Stamp 4 visa. Please note that we are unable to provide visa sponsorship. Thank you for your understanding. Apply via this advert or contact Siobhan Cummins on if you have any more questions about this opportunity!

Purpose An exciting opportunity has arisen for a Quality Assurance Specialist to join our team.

The role ensures that the QA team objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers, as well as meeting Health Agency regulations and all other applicable governing regulations.

This position will report directly to the Quality Assurance COE Lead.

Requirements Support various site functional and cross-functional tier structures.

Completes review and approval for CAPAs, change requests, investigative protocols, and final reports.

Responsible for the quality aspects of material and supplier management, such as compilation of material qualification pack, supplier audit review, and supplier management system upkeep.

Involved in the development and review of documentation and quality records in collaboration with other stakeholders such as QC, MS&T, Engineering, and Warehouse throughout the product lifecycle e.g., method validation, facility upgrades, qualification protocols, calibration records.

Review and approve GMP documentation/data for accuracy and completeness.

Working cross-functionally to ensure project milestones are met in a timely manner.

Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans.

A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant c GMPs, regulations and current industry trends.

Strong collaboration and cross-functional leadership skills.

Strong verbal and written communication skills, project management skills.

Requirements Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Engineering or Supply Chain in a relevant discipline.

5 years' experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.

2 years of experience in performing the release function in a regulated environment Strong knowledge of qualification and implementation of single-use technologies and raw materials for use in a GMP environment.

Strong contemporary knowledge of relevant c GMPs, regulations, and current industry trends.

Proven track record in delivering excellence.

Knowledge of SAP, KNEAT, and Veeva systems is an advantage.

Skills: SAP KNEAT CAPA Document Review

LSC have a great opportunity for a Senior QA Specialist to join a South Dublin-based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.

If you have 7+ years of experience in construction management/engineering within the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect project for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products Quality review and approval of Process Development and Validation documentation Technical transfer documents Validation Protocols, executed validation documents and reports Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records ABOUT YOU - ARE YOUR SKILLS A MATCH? Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1 G visa or a Stamp 4 visa.

Please note that we are unable to provide visa sponsorship.

Thank you for your understanding.

Apply via this advert or contact Siobhan Cummins on if you have any more questions about this opportunity!

Quality Assurance Specialist (hybrid) RK4599 Contract 12 months Dublin 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. Duties: Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring that all activities meet company and regulatory expectations. Quality review and approval of Process Development and Validation documentation - Technical transfer documents - Validation Protocols, executed validation documents and reports Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely. Perform all activities in compliance with safety standards and SOPs In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role Educational and Experience University degree. Engineering or Science related discipline preferred. Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role Understanding of principles of Validation and New Product Introduction Experience in aseptic manufacturing If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.

POSITION SUMMARY This position will report directly to the Rathdrum Site Quality Operations (QO) Lead and will serve as partners alongside other stakeholders to ensure compliance and execution of site operational activities and ensure the site is permanently inspection ready. The Rathdrum QA Specialist-Operations will have responsibility for ensuring that the process for the manufacture of Active Pharmaceutical Ingredients is in compliance with cGMP and the associated regulatory requirements. The QA Specialist- Operations may be required to perform tasks required by QA Specialist - QSS or QA Specialist - Batch Release on a case by case basis where needed, once trained to do so POSITION RESPONSIBILITIES Key objectives of this position include: Provision of Quality oversight and support for Operations in the following key area/activities; manufacturing, testing, packaging and material management across all phases of development and commercial manufacture in terms of ensuring that GMP activities are in compliance with regulatory, corporate and site procedures. Provide in plant/on the shop floor support and guidance for GMP product quality assurance and compliance for Manufacturing Operations, Laboratory Operations and Warehousing activities including but not limited to Batch Manufacturing and Analytical Testing, Deviations, Change Control, CAPA's and Training Review /Approve Master Batch Record (MBR), Master Cleaning Records (MCR), Master Set Up Records (MSUR), Master Analytical Records (MAR) Issuance of Batch Records and Cleaning Records Review of executed Batch Records and Cleaning Records as per site procedures. Quality reviewer of SOPs, EOPs, Change Requests, Protocols, Reports, etc. Quality Business Partner for PPQ, CPV and APR activities, partnering with GMT, Laboratories, Operations and Regulatory to ensure successful transfer and validation of processes Quality Business partner for Engineering Change Control and Equipment Calibration and Qualification and Facility Recommissioning (CQV) to ensure Qualified equipment and Facilities are provided to Operations for Batch Manufacture Quality Support for Utilities and Facility Support Systems E.g. Water, Nitrogen, Environmental Monitoring and Cleaning Validation Systems. Support in ensuring compliant systems and processes are in place, validated and executed as intended. Support in Councils and Team meetings to ensure data is trended and all deviations are investigated and changes assessed. QA Release of Intermediates Common Responsibilities for all Quality Colleagues Active participation in site Tier meetings Perform/Lead Internal Audits/Quality Walkthroughs. Support Internal Inspection Readiness, Corporate and Regulatory Inspections. Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean methodology, ensuring quality is built in and all corporate and regulatory requirements are met Serving as a quality culture role model and instill a strong quality and compliance culture across the site. Assure the use of operational excellences tools in quality procedures and processes, Support the development of quality goals and targets as part of the organisation's strategic plan, Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean methodology, Comply with the relevant Safety Statutory provisions, and in particular must take reasonable care for their own safety and that of others who may be affected by their acts or omissions at work. All employees must comply with the site's safety rules and instructions, and must report all accidents, injuries, defects or situations which they believe could present a hazard to themselves or others. Required to safeguard company assets and ensure that all resources are expended or consumed in a prudent manner. Perform role to a high standard and deliver on all assigned objectives/duties. ORGANIZATIONAL RELATIONSHIPS Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate. This position will need to achieve results through colleagues with a direct reporting relationship as well as indirectly, as part of the site recommissioning core project team through to commercialisation. All employees must adhere and comply with cGMP requirements, including Quality Manuals, Policies and Procedures. All employees are expected to model inclusion behaviours. Each team member can influence and bring knowledge to their work teams during their day-to-day interactions. EDUCATION AND EXPERIENCE Undergraduate degree in pharmaceutical, biological or chemical sciences Relevant advanced degree preferred 5+ years relevant experience in Pharmaceutical and/or Animal Health industry, with a current knowledge of cGMP's and regulatory guidance required. Significant experience in Equipment Commissioning/ Qualification, Cleaning Validation and Process Validation is desirable. Success in developing, implementing and maintaining Quality Systems and Standards at manufacturing site level in accordance with ICHQ10 key principles ICHQ7 Manufacturing Site experience preferred Recognised LSS Qualification (Yellow belt, Green Belt, Black Belt) desirable TECHNICAL SKILLS AND COMPETENCIES REQUIRED Demonstrated knowledge and success in working with cross functional teams e.g. supplier management. Ability to develop and adhere to self-directed standard work- organized and methodical with ability to take initiative with minimal guidance and be comfortable working both as an individual and as part of a team Exercises Good Judgment and Drives Change for Competitive Advantage Strong written and oral communication skills and ability to collaborate effectively with others Strong interpersonal, leadership and influencing Skills, communication and motivation. Drives for Superior Results and Passion to Win with demonstrated record in getting things done Inspires Continuous Improvement and Breakthrough Thinking - flexible and adaptable to new and innovative ideas Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with division and corporate objectives Proficient in English Demonstrated written communication skills, as well as experience with presenting to leadership teams. Assertive Business Awareness & Continuity PHYSICAL POSITION REQUIREMENTS This is Rathdrum, Ireland Site based position Travel may be required as part of the role, as needed to support audits - approx. up to 10% of the time. This position will require fluent use of teleconferencing tools, as well as SharePoint technologies, to share and manage information with Global Quality Centre Organization and other Zoetis internal API manufacturing network. Full time Legal statement as below This job advert indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent. Incumbent may be asked to perform other duties as required. Additional position specific requirements/responsibilities are contained in approved training curricula. Visa status re must be eligible to work and live in Ireland as below Colleague must be legally eligible to live and work in Ireland. Summary of our Benefits In addition, to being part the world leading animal health company focused on the needs of those who raise and care for animals we offer a range of benefits such as competitive salary, bonus, 25.5 days holiday per annum plus public holidays, a defined contributory pension plan, private medical insurance for you and your family and empowered flexible working, to name a few. Please note that the benefits outlined are subject to change based on organization decision. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Apply button below to Login/Register.

Quality Assurance Specialist (hybrid) RK4599 Contract 12 months Dublin 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.

Duties: Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring that all activities meet company and regulatory expectations.

Quality review and approval of Process Development and Validation documentation - Technical transfer documents - Validation Protocols, executed validation documents and reports Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.

Perform all activities in compliance with safety standards and SOPs In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role Educational and Experience University degree.

Engineering or Science related discipline preferred.

Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role Understanding of principles of Validation and New Product Introduction Experience in aseptic manufacturing If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.

POSITION SUMMARY This position will report directly to the Rathdrum Site Quality Operations (QO) Lead and will serve as partners alongside other stakeholders to ensure compliance and execution of site operational activities and ensure the site is permanently inspection ready.

The Rathdrum QA Specialist-Operations will have responsibility for ensuring that the process for the manufacture of Active Pharmaceutical Ingredients is in compliance with c GMP and the associated regulatory requirements.

The QA Specialist- Operations may be required to perform tasks required by QA Specialist - QSS or QA Specialist - Batch Release on a case by case basis where needed, once trained to do so POSITION RESPONSIBILITIES Key objectives of this position include: Provision of Quality oversight and support for Operations in the following key area/activities; manufacturing, testing, packaging and material management across all phases of development and commercial manufacture in terms of ensuring that GMP activities are in compliance with regulatory, corporate and site procedures.

Provide in plant/on the shop floor support and guidance for GMP product quality assurance and compliance for Manufacturing Operations, Laboratory Operations and Warehousing activities including but not limited to Batch Manufacturing and Analytical Testing, Deviations, Change Control, CAPA's and Training Review /Approve Master Batch Record (MBR), Master Cleaning Records (MCR), Master Set Up Records (MSUR), Master Analytical Records (MAR) Issuance of Batch Records and Cleaning Records Review of executed Batch Records and Cleaning Records as per site procedures.

Quality reviewer of SOPs, EOPs, Change Requests, Protocols, Reports, etc.

Quality Business Partner for PPQ, CPV and APR activities, partnering with GMT, Laboratories, Operations and Regulatory to ensure successful transfer and validation of processes Quality Business partner for Engineering Change Control and Equipment Calibration and Qualification and Facility Recommissioning (CQV) to ensure Qualified equipment and Facilities are provided to Operations for Batch Manufacture Quality Support for Utilities and Facility Support Systems E.g.

Water, Nitrogen, Environmental Monitoring and Cleaning Validation Systems.

Support in ensuring compliant systems and processes are in place, validated and executed as intended.

Support in Councils and Team meetings to ensure data is trended and all deviations are investigated and changes assessed.

QA Release of Intermediates Common Responsibilities for all Quality Colleagues Active participation in site Tier meetings Perform/Lead Internal Audits/Quality Walkthroughs.

Support Internal Inspection Readiness, Corporate and Regulatory Inspections.

Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean methodology, ensuring quality is built in and all corporate and regulatory requirements are met Serving as a quality culture role model and instill a strong quality and compliance culture across the site.

Assure the use of operational excellences tools in quality procedures and processes, Support the development of quality goals and targets as part of the organisation's strategic plan, Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean methodology, Comply with the relevant Safety Statutory provisions, and in particular must take reasonable care for their own safety and that of others who may be affected by their acts or omissions at work.

All employees must comply with the site's safety rules and instructions, and must report all accidents, injuries, defects or situations which they believe could present a hazard to themselves or others.

Required to safeguard company assets and ensure that all resources are expended or consumed in a prudent manner.

Perform role to a high standard and deliver on all assigned objectives/duties.

ORGANIZATIONAL RELATIONSHIPS Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities.

Include any external interactions as appropriate.

This position will need to achieve results through colleagues with a direct reporting relationship as well as indirectly, as part of the site recommissioning core project team through to commercialisation.

All employees must adhere and comply with c GMP requirements, including Quality Manuals, Policies and Procedures.

All employees are expected to model inclusion behaviours.

Each team member can influence and bring knowledge to their work teams during their day-to-day interactions.

EDUCATION AND EXPERIENCE Undergraduate degree in pharmaceutical, biological or chemical sciences Relevant advanced degree preferred 5+ years relevant experience in Pharmaceutical and/or Animal Health industry, with a current knowledge of c GMP's and regulatory guidance required.

Significant experience in Equipment Commissioning/ Qualification, Cleaning Validation and Process Validation is desirable.

Success in developing, implementing and maintaining Quality Systems and Standards at manufacturing site level in accordance with ICHQ10 key principles ICHQ7 Manufacturing Site experience preferred Recognised LSS Qualification (Yellow belt, Green Belt, Black Belt) desirable TECHNICAL SKILLS AND COMPETENCIES REQUIRED Demonstrated knowledge and success in working with cross functional teams e.g.

supplier management.

Ability to develop and adhere to self-directed standard work- organized and methodical with ability to take initiative with minimal guidance and be comfortable working both as an individual and as part of a team Exercises Good Judgment and Drives Change for Competitive Advantage Strong written and oral communication skills and ability to collaborate effectively with others Strong interpersonal, leadership and influencing Skills, communication and motivation.

Drives for Superior Results and Passion to Win with demonstrated record in getting things done Inspires Continuous Improvement and Breakthrough Thinking - flexible and adaptable to new and innovative ideas Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with division and corporate objectives Proficient in English Demonstrated written communication skills, as well as experience with presenting to leadership teams.

Assertive Business Awareness & Continuity PHYSICAL POSITION REQUIREMENTS This is Rathdrum, Ireland Site based position Travel may be required as part of the role, as needed to support audits - approx.

up to 10% of the time.

This position will require fluent use of teleconferencing tools, as well as Share Point technologies, to share and manage information with Global Quality Centre Organization and other Zoetis internal API manufacturing network.

Full time Legal statement as below This job advert indicates the general nature and level of work expected.

It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent.

Incumbent may be asked to perform other duties as required.

Additional position specific requirements/responsibilities are contained in approved training curricula.

Visa status re must be eligible to work and live in Ireland as below Colleague must be legally eligible to live and work in Ireland.

Summary of our Benefits In addition, to being part the world leading animal health company focused on the needs of those who raise and care for animals we offer a range of benefits such as competitive salary, bonus, 25.5 days holiday per annum plus public holidays, a defined contributory pension plan, private medical insurance for you and your family and empowered flexible working, to name a few.

Please note that the benefits outlined are subject to change based on organization decision.

To be considered for this role you will be redirected to and must complete the application process on our careers page.

To start the process click the Apply button below to Login/Register.

Quality Assurance Specialist Supplier & Vendor Compliance About Your New Employer Join a leading global company renowned for its commitment to quality and innovation in the pharmaceutical and biotechnology sectors. Be part of a dynamic team that values professional growth, continuous learning, and excellence in quality assurance. Work in a collaborative environment with opportunities to engage in global projects and initiatives. About Your New Job Lead Auditor: Conduct supplier audits (initial, routine, for-cause), prepare audit reports, track CAPAs, and verify implementation effectiveness. Global QA Support: Provide QA input into procurement decisions and cross-functional sourcing teams to ensure GxP compliance. Supplier Qualification: Lead the development, implementation, and continuous improvement of the supplier qualification program, including risk-based classification, audit planning, and ongoing performance monitoring. Documentation Review: Review and approve supplier quality documentation, such as Technical/Quality Agreements, audit responses, change notifications, and deviation reports. Training and Development: Develop and deliver internal training on supplier qualification procedures and regulatory expectations. What Skills You Need Lead Auditor Qualification: Must be lead auditor trained with a recognized qualification. Educational Background: Masters degree in a science discipline. Experience: Minimum of 10 years of overall experience with at least 3 years in auditing vendors/suppliers. Travel: Willingness to travel approximately 5 to 10 times throughout the year for vendor audits. Technical Skills: Strong understanding of quality systems, technical agreements, and risk-based approaches to supplier qualification. Whats on Offer Competitive Salary: Attractive compensation package. Professional Development: Opportunities for training and career advancement. Whats Next Apply now by clicking the Apply Now" button or call me, Ross Keyes on . If the job isnt quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC, and Contract jobs available. Skills: Raw Material audit Benefits: Paid Holidays Pension Bonus Life Assurance Permanent Health Insurance

Quality Assurance Specialist Supplier & Vendor Compliance About Your New Employer Join a leading global company renowned for its commitment to quality and innovation in the pharmaceutical and biotechnology sectors.

Be part of a dynamic team that values professional growth, continuous learning, and excellence in quality assurance.

Work in a collaborative environment with opportunities to engage in global projects and initiatives.

About Your New Job Lead Auditor: Conduct supplier audits (initial, routine, for-cause), prepare audit reports, track CAPAs, and verify implementation effectiveness.

Global QA Support: Provide QA input into procurement decisions and cross-functional sourcing teams to ensure Gx P compliance.

Supplier Qualification: Lead the development, implementation, and continuous improvement of the supplier qualification program, including risk-based classification, audit planning, and ongoing performance monitoring.

Documentation Review: Review and approve supplier quality documentation, such as Technical/Quality Agreements, audit responses, change notifications, and deviation reports.

Training and Development: Develop and deliver internal training on supplier qualification procedures and regulatory expectations.

What Skills You Need Lead Auditor Qualification: Must be lead auditor trained with a recognized qualification.

Educational Background: Masters degree in a science discipline.

Experience: Minimum of 10 years of overall experience with at least 3 years in auditing vendors/suppliers.

Travel: Willingness to travel approximately 5 to 10 times throughout the year for vendor audits.

Technical Skills: Strong understanding of quality systems, technical agreements, and risk-based approaches to supplier qualification.

Whats on Offer Competitive Salary: Attractive compensation package.

Professional Development: Opportunities for training and career advancement.

Whats Next Apply now by clicking the Apply Now" button or call me, Ross Keyes on.

If the job isnt quite right but you are looking for something similar, please get in touch.

We also have multiple Temp, FTC, and Contract jobs available.

Skills: Raw Material audit Benefits: Paid Holidays Pension Bonus Life Assurance Permanent Health Insurance