Description
Purpose of the Job:To ensure compliance with regulatory requirements by timely review and release of batch documentation and conducting process, packing, cleaning and temperature mapping validation of all areas against the regulatory standards.
Specific Key Result Areas:
·Routine Product Release: To conduct documentation review of entire batch package in line with regulatory requirements, including where applicable, OOS /Stability reports.
·New Products/Validation: To generate, review and conduct process, packing, cleaning and temperature mapping validation reports in line with current regulations and industry best practice, within required timelines. Quality support for introduction of new products, equipment and facilities.
·Quality Systems Development: To develop and improve quality systems by identifying areas for improvement (NVAA's and key variances) and take corrective action as required to ensure continuous improvement in accordance with Company Continuous Improvement Process.
·Review and approval of change proposals and related documentation for compliance with regulatory approvals and GMP requirements.
·Participate in CI activities / projects / root cause analysis and solution implementation to enhance the product value streams.
·To conduct simulated IMB/FDA systems inspections to ensure the company is at all times ready for audit. Conduct audits of Suppliers where necessary and provide assistance to the Vendor Certification Programme.
The successful candidate should possess the following:
·Degree/Diploma or equivalent in Pharmaceutical/Life Sciences with two years experience in a Validation or QA environment.
·In depth knowledge and understanding of interpretation of cGMPs and regulatory requirements, experience of regulatory inspections and customer audits.
·Ability to participate in day to day activities and projects by providing Quality support.
This is an urgent need so if you would like to apply for the position please contact Sarah Irvine on or reply with a copy of your CV. We also offer £200 worth of vouchers for any successful referrals so if you know anyone who is looking for opportunities please get in touch.