Reporting to the Site Quality Operations Lead, the QA Operations Specialist will be responsible for ensuring the process for producing Active Pharmaceutical Ingredients aligns with cGMP and regulatory standards.
Responsibilities
- Overseeing and supporting operational aspects in critical areas such as manufacturing, testing, packaging, and material management throughout development and commercial manufacturing phases.
- Ensures compliance with GMP regulations, corporate standards, and site procedures.
- Provides on-site guidance for GMP product quality assurance and compliance, spanning Manufacturing Operations, Laboratory Operations, and Warehousing. Covers Batch Manufacturing, Analytical Testing, Deviations, Change Control, CAPA, and Training.
- Reviews and approves Master Batch Records, Cleaning Records, Set Up Records, and Analytical Records.
- Issues Batch and Cleaning Records.
- Assesses executed Batch and Cleaning Records as per site procedures.
- Reviews SOPs, EOPs, Change Requests, Protocols, Reports, etc.
- Acts as Quality Business Partner for PPQ, CPV, and APR activities, collaborating with GMT, Laboratories, Operations, and Regulatory for seamless process transfer and validation.
- Partners in Engineering Change Control, Equipment Calibration, Qualification, and Facility Recommissioning (CQV) to ensure qualified equipment and facilities for Batch Manufacture.
- Provides Quality Support for Utilities, Facility Support Systems, and participates in councils and team meetings to ensure compliant systems and effective deviation management.
- Has QA authority for releasing intermediates.
Requirements
- 4+ years experience in Pharmaceutical and/or Animal Health industry.
- Relevant degree in pharmaceutical, biological or chemical sciences.
- LSS Qualification (Yellow belt, Green Belt, Black Belt) desirable.
Randstad encourage applications from individuals of all ages and backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment and an employment business for temporary recruitment as defined by the Conduct of Employment Agencies and Employment Business Regulations 2003
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