Job Description
Cpl, in partnership with our client Pfizer, is seeking a QA Validation Specialist to join the team at their state-of-the-art Dublin facility for an 11-month fixed-term contract with a hybrid working model.
Role Overview
To provide a comprehensive compliance overview of sitewide validation activities, offering technical QA support to various functions, including Engineering, Automation, Technical Operations, Technical Services, Business Technology (BT), and Quality Control (QC).
Key Responsibilities
* Support quality oversight of qualification, validation (and re-validation as necessary) through the review and approval of validation documents for equipment, utilities, control systems, cleaning validations, and other related items.
* Ensure compliance with corporate standards, internal procedures, regulatory requirements, and industry standards, while staying current with all training requirements.
* Provide support on compliance issues to Engineering, Automation, BT, Technical Operations, Technical Services, and QC.
* Offer guidance to cross-functional, multi-departmental project teams on quality regulations for validation strategy and approach.
* Act as a key member of Quality Risk Management and Operational Excellence, aiming to improve efficiencies and promote continuous improvement.
* Review and approve validation protocols, procedures, specifications, reports, validation deviations, and project plans as required.
* Review Policies and Master Plans.
* Ensure change controls and automation change requests are compliant with applicable procedures, maintaining the validated state.
* Support the timely release of equipment, utilities, facilities, and computer systems following validation activities.
* Participate in site self-inspections, internal audits, board of health audits, and third-party audits.
* Support Biotech Communities of Practice (COP) and Common Interest Groups (CIGs) as needed.
* Provide support to Operational Units (OpUs), site projects, and participate in cross-functional teams as required.
Education and Experience Requirements
* Bachelor's degree or equivalent in a technical subject area.
* 2-3 years of work experience in a pharmaceutical environment.
* Excellent communication and interpersonal skills.
* Ability to work independently and collaboratively within a dynamic, fast-paced environment.