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Job Description
Responsibilities
- 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 the company.
- Provide 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, including aseptic intervention observation.
- Lead/Assist in investigations arising out of product or manufacturing processes non-compliance.
- Review/Audit completed Batch Records.
- Review Manufacturing Logs as required.
- Complete quality review of operations documentation (SOPs, JSTMs, Risk Assessments).
- Complete Line Clearance activities.
- Complete Incoming Raw Material checks, including product status maintenance (as required).
- Provide Stability Program Support, e.g., sample pulls, weekly checks, protocol generation (as required).
- Maintain finished product status, including labeling as required.
- Administer Quality Logs, e.g., QA Hold, Sample Request.
- 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.
- Other support as deemed necessary.
- Third level degree in a science, quality, or engineering discipline.
- Ideally previous experience in a quality role.
- A minimum of three years' experience in a quality/operations role in a highly regulated GMP environment. Experience in biologics manufacturing is highly desirable.
- Experience in aseptic processing gained within either a quality or operations role is highly desirable.
- A strong knowledge of regulatory requirements is required.