QA Validation Specialist

3 weeks ago

Dublin, Dublin City, Ireland Cpl Full time

Cpl in partnership with our client Pfizer are currently recruiting for a QA Validation Specialist for an initial 11 months contract based in their Grange Castle Site.

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:

General


• Ensure compliance with cGMP, corporate standards/Pfizer Quality System (PQS), site policies/procedures, regulatory requirements and industry standards.


• Partner closely with customers and stake-holders to understand and deliver on all records within timelines and escalate when necessary.


• Participate in cross functional teams as required to provide consultative support on quality related issues. Provides support with investigations and resolution of discrepancies e.g. Method 1 etc. Assures completeness in terms of root cause, action taken, and CAPA.


• Authors, tracks, review for adequacy: procedures, investigations, commitments (Regulatory Agency, investigation, audit, etc), change controls, forms, logbooks, protocols and reports etc.


• 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.


• To 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.


• To review and approve validation protocols, procedures, specifications, reports, validation deviations and project plans as required.


• To 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.

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