QA Validation Specialist

A QA Validation Specialist is required by Careerwise recruitment to work with a Co. Clare based biopharmaceutical client.

    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:

* 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.

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.

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