QA Validation Specialist
Primary stack
Job description
About the Position
Cpl in partnership with our client Pfizer are seeking a QA Validation Specialist to join the team at their state-of-the-art Dublin, Grange Castle Plant for an 11-month fixed-term contract with a hybrid working model. The role involves providing a compliance overview of sitewide validation activities and technical QA support to various functions.
Responsibilities
- Support quality oversight of qualification, validation (and appropriate re-validation) activities through the review and approval of validation documents for equipment, utilities, control systems, cleaning validations, and others.
- Ensure compliance with corporate standards, internal procedures, regulatory requirements, and industry standards, and stay current with all training requirements.
- Provide support on compliance issues to Engineering, Automation, Business Technology (BT), Technical Operations, Technical Services, and QC.
- Provide guidance to cross-functional, multi-departmental project teams on quality regulations for validation strategy and approach.
- Review and approve validation protocols, procedures, specifications, reports, validation deviations, and project plans as required.
- Review Policies and Master Plans.
- Ensure that change controls and automation change requests are compliant with applicable procedures and maintain the validated state.
- Support the timely release of equipment, utilities, facilities, and computer systems following validation activities.
- Support and participate in site self-inspections, internal audits, board of health audits, and third-party audits.
- Actively support Biotech Communities of Practice (COP) and Common Interest Groups (CIGs) as required.
- Provide support to the Operational Units (OpU’s), site projects, and participate in cross-functional teams as required.
Requirements
- BSc or Engineering degree in a technical-based subject.
- 2-3 years of working experience in a pharmaceutical environment.
- Excellent communication and interpersonal skills.
- Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
We Offer
- 11-month contract with a hybrid working model.
- Opportunity to work with a leading pharmaceutical company, Pfizer.
About the Company
Pfizer is a global pharmaceutical company known for its innovative medicines and vaccines. Working with Pfizer offers a unique opportunity to contribute to groundbreaking research and development in the pharmaceutical industry.
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Cpl is a Global provider of workforce solutions to startup companies, multinationals and SMEs in every sector from Pharmaceuticals to Fund Accounting.Founded in 1989, the Cpl Group now comprises 22 brands spanning more than 41 offices in 11 countries.Cpl’s core goal is to power business growth through people. Each of our Cpl divisions and brands offers innovative, sector-focused solutions across recruitment, outsourcing, training, and consultancy. We offer a combination of scale and industry-expertise across the group with over 300 recruitment consultants dedicated to specific sectors and skillsets, including:• IT• Construction• Science• Customer Support• Engineering• Finance• Retail• Banking• HR• Sales• Administration• Marketing• Supply Chain