QA Validation Specialist
Dublin 22, Grange Castle
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
·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.