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QA Validation Specialist
4 weeks ago
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 Hybrid working model.
Role:
To provide a compliance overview of sitewide validation activities. To provide technical QA support to the Engineering function (including Automation), Technical Operations, Technical Services, Business Technology (BT) and QC.
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, BT, Technical Operations, Technical Services and QC.
- Provide guidance to cross-functional, multi-departmental project teams on quality regulations for Validation strategy and approach.
- Key member of Quality Risk Management and Operational Excellence to improve efficiencies and to promote continuous improvement.
- 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.
Education/Experience Requirements:
- B.Sc. or Eng degree in a technical based subject.
- 2-3 years working experience in a pharmaceutical environment.
- Excellent communication and interpersonal skills.
- An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
