QA Validation Specialist

Summary:
Our client is a global Biologics company based in Dunboyne and is looking for a QA Validation Specialist. This role will be responsible for providing quality support to site qualification activities, including capital projects and re-qualification activities within a state-of-the-art, single-use facility.

Responsibilities:

• Quality oversight of GMP compliance for engineering and validation deliverables related to site and capital projects including requirements definition, specification, engineering design, qualification and change management.
• Review and approval of validation protocols, reports, procedures and other related documents to ensure compliance to internal procedures and regulatory requirements.
• Evaluation and approval of deviations related to validation protocols in order to guarantee proper tracking/ documentation of the incidents and identification of corrective actions.
• Collaboration and participation in projects as a Quality Representative for Validation.
• Providing validation expertise and support for the development (or modification) of manufacturing facilities, equipment & systems.
• Participation in the evaluation of Change Control and providing support in the review of the associated risk assessments.
• Supporting process deviation evaluation with regards to validation impact.
• Ensuring the validation maintenance activities are executed as required including approval in a timely manner of the re-qualification / re-validation activities.
• Providing subject matter expert (SME) support for general troubleshooting, problem solving, technical direction and guidance to support overall business needs.
• Maintaining up-to-date knowledge of pharmaceutical legislation and industry best practice.
• Timely updates of site achievements and challenges and taking a collaborative approach, working cross-functionally on resolving obstacles to maintain a highly effective and productive functional group.

Qualifications & Experience:

• Bachelor’s Degree in sciences or Engineering (Chemistry, Biology, Pharmacy, Microbiology, etc.).
• Minimum of 5 years’ experience in a QA/Validation related position within the pharmaceutical or life-sciences industry.
• Strong experience with Validation in project related activities, including Controlled Area Facilities.
• Strong experience in Validation to ensure compliance to Annex 15, EU regulations and applicable US FDA Guidelines.
• Knowledge of/experience with aseptic processing and biologicals.
• Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of pharmaceutical and/or biological products.
• Track record of utilising Risk Based Approaches to Qualification / Validation activities.
• Strong track record of identifying, escalating and correcting compliance issues and implementing process improvements.
• Training Material development and deployment.