QA Validation Specialist

On behalf of our client, we are looking for a QA Validation Specialist to join their Quality Assurance Validation team in their state of the art biotech facility in Co. Meath.
This 6 month contract is a great opportunity to gain invaluable experience within the QA validation field with a leading name in the biotech industry

Key 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.

Key Requirements:
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.
Detail oriented with ability to multitask

For further information on this role in please contact Maraleeze Keane on (phone number removed) or email
Check out all our open jobs on our HERO Recruitment website – (url removed)

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.