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 & Education

• Bachelor’s Degree
• Experience in a QA/Validation
• Experience with Validation in project related activities, including Controlled Area Facilities.
• Experience in Validation to ensure compliance to Annex 15, EU regulations and applicable US FDA Guidelines.
• Knowledge of/experience with aseptic processing and biologicals.
• Track record of utilising Risk Based Approaches to Qualification / Validation activities.
• Track record of identifying, escalating and correcting compliance issues and implementing process improvements.
• Training Material development and deployment.
• Detail oriented with ability to multitask

To apply contact Martin Lynch on 087-344 3581.

Email CVs to mlynch@mile.ie