Manufacturing Compliance Specialist
- 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 products.
- 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 labeling 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 2 years experience in a similar position
- Strong knowledge of the regulatory requirements
- Strong communication skills both verbal and written