QA Validation Engineer

A QA Validation Engineer is required by CareerWise recruitment with our Clare based biotech client.

Role of this position

• 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.
• Support generation of Process and QC Equipment Installation, and Operational and Performance Qualifications, review and approve the Qualification protocols, discrepancies and reports for Quality.
• Provide QA support to data integrity compliance activities across the site. Write or assist in the writing of Policies, SOPs, work instructions and forms for validation requirements and other quality systems as required.

JOB REQUIREMENTS

• BSC in Science / 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, including Computer System Validation e.g. EU/FDA GMP guidelines, EU Annex 15, PIC/S & GAMP guidelines, EU Annex 11 & CFR Part 11 and ICH Q9.
• Knowledge of cell culture-based manufacturing techniques and requirements and cellular and gene therapies.

Please call Michael O'Connor today for further information on 091-452410 or email moconnor@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.