Job Description
A QA Validation Specialist is required to work with a biopharmaceutical client based in Co. Clare.
The Role:
* Preparation and Maintenance of the site validation plan.
* Maintenance and archiving of Validation/Qualification documentation.
* Interface with other departments such as Engineering, QC Laboratories, Operations, Supply Chain and Process Development to ensure that validation project plans are understood and adhered to.
* Review and approve validation, qualification protocols and reports.
* Maintain understanding of cGMP, Good Engineering Practices and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities.
* Support generation of Process and QC Equipment Installation, and Operational and Performance Qualifications, review and approve the Qualification protocols, discrepancies and reports for Quality.
* Support Regulatory Inspections and third party audits.
Requirements:
* Bachelor's degree in Science or Engineering.
* Strong Quality Assurance background working in a Pharmaceutical or Biotech Production environment within sterile manufacturing.
* Extensive experience with providing QA technical support and oversight to validation and qualification activities and with implementing the concepts, legislation, guidelines and requirements related to qualification and validation of sterile products, aseptic processes, equipment and systems.
The ideal candidate will have experience with EU/FDA GMP guidelines, EU Annex 15, PIC/S & GAMP guidelines, EU Annex 11 & CFR Part 11 and ICH Q9.
We estimate the salary for this role to be around €50,000 - €70,000 per annum, depending on experience.