QA Compliance Specialist
4 weeks ago
• Leading / Assisting in investigations arising out of productor manufacturing processes non-compliance.
• 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 Incoming Raw Material checks, including product status maintenance (as required).
• Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation (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.
• Other support as deemed necessaryQualifications and Experience: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.
• Experience in aseptic processing gained within either a quality or operations role is highly desirable.
• A strong knowledge of regulatory requirements is required. Cognitive Skills
• Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
• Requires proven problem-solving skills and the ability to adapt tonew requirements.For more information and a full job spec contact Nicola on (phone number removed) or email your CV in the strictest confidence to (email address removed)
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