GerTEK Project Management & Technical Services is seeking to recruit a Manufacturing Compliance Specialist to join our team.
- Ensure that all products leaving meet the standards required for marketed and investigational drug products.
- Ensure that products and aseptic process simulations manufactured meet the requirements of the end users, regulatory authorities and of the company.
- Providing quality and compliance oversight and assistance to the Operations function of the company to manufacture products in compliance with all site policies and procedures.
- Provide quality oversight during the aseptic processing of product Leading / Assisting in investigations arising out of product or manufacturing processes non-compliance.
- Review/Audit of completed Batch Records.
- Review of Manufacturing Logs as required.
- Completion of Line Clearance activities.
- Completion of Incoming Raw Material checks, including product status maintenance.
- Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation as required.
- Finished product status maintenance, including labelling as required.
- Administration of Quality Logs, e.g. QA Hold, Sample Request, VCR.
- Lead operations floor daily walk around of manufacturing areas.
- Drive continuous improvements and simplify site processes and procedures, specifically relating to the Operations function to ensure compliance is maintained at all times.
Qualifications and Experience
- A third level qualification in a science, quality or relevant discipline
- At least 5 years’ experience in a similar position
- Strong knowledge of regulatory requirements
- Quality systems experience and familiar with vendor evaluation, qualification, coordination of change management process etc.
Shift work required