Job Description
This is an important role within the business and will provide quality and compliance oversight and assistance to the Operations function.
About the Role:
* Ensure that all products leaving facility meet the standards required for marketed and investigational drug products.
* 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.
* Lead / Assist in investigations arising out of product or manufacturing processes non-compliance.
Responsibilities:
Providing quality and compliance oversight and assistance to the Operations function includes but not limited to:
• Review/Audit of completed Batch Records.
• Review of Manufacturing Logs as required.
• Completion of quality review of operations documentation (SOPs, JSTMs, Risk Assessments).
• Completion of Line Clearance activities.
• Completion of Incoming Raw Material checks, including product status maintenance (as required).
• 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.
• Lead operations floor daily walk around of manufacturing areas.
• Drive continuous improvements and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times.
Requirements:
* Third level degree in a science, quality or engineering discipline.
* A minimum of three years experience in a quality/operations role in a highly regulated GMP environment.
* Experience in biologics manufacturing is highly desirable.
* A strong knowledge of regulatory requirements is required.