QA Validation Specialist

1 month ago

Dublin, 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.



â¢Â Â Â Â Â Â 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.

â¢Â Â Â Â Â Â To ensure compliance with corporate standards, internal procedures, regulatory requirements and industry standards, and stay current with all training requirements.

â¢Â Â Â Â Â Â Provide support on compliance issues to Engineering, Automation, BT, Technical Operations, Technical Services and QC.

â¢Â Â Â Â Â Â Provide guidance to cross-functional, multi-departmental project teams on quality regulations for Validation strategy and approach.

â¢Â Â Â Â Â Â Key member of Quality Risk Management and Operational Excellence to improve efficiencies and to promote continuous improvement.

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

â¢Â Â Â Â Â Â To review Policies and Master Plans.

â¢Â Â Â Â Â Â Ensure that change controls and automation change requests are compliant with applicable procedures and maintain the validated state.

â¢Â Â Â Â Â Â Support the timely release of equipment, utilities, facilities and computer systems following validation activities.

â¢Â Â Â Â Â Â Support and participate in site self-inspections, internal audits, board of health audits and third party audits.

â¢Â Â Â Â Â Â Actively support Biotech Communities of Practice (COP) and Common Interest Groups (CIGs) as required.

â¢Â Â Â Â Â Â Provide support to the Operational Units (OpUâs), site projects and participate in cross-functional teams as required.


Education/Experience Requirements:

â¢Â Â Â Â Â Â B.Sc. or Eng degree in a technical based subject.

â¢Â Â Â Â Â Â 2-3 years working experience in a pharmaceutical environment.

â¢Â Â Â Â Â Â Excellent communication and interpersonal skills.

â¢Â Â Â Â Â Â An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.

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