QC Manager – Pharmaceuticals
A growing pharmaceutical manufacturer have an exciting opportunity for a QC Manager to join the team. You will lead a small team of QC and Senior QC analysts to help set up, organise and the analytical lab. You must have significant experience working in a pharmaceutical chemistry QC environment and have prior team management experience.
• Set up, organise and run the day to day operations of pharmaceutical QC testing laboratory
• Lead the team responsible for carrying out Quality Control analysis on Incoming Materials, Components and Products (including stability and other samples) and data to support manufacturing and QC functions.
• Ensures that QC functions operate in a fully GMP compliant manner and in compliance with the filed regulatory dossiers for the products supported.
• Day to day management of a team of Analysts and Senior Analysts and drive compliance of work to agreed timelines.
• Responsible for safety of team members, ensuring that all staff are suitably qualified and trained to undertake the tasks assigned to them in a safe and compliant manner.
• Train, coach and mentor team members primarily by acting as a positive role model in all instances;
• Write, review, approve and implement SOP's, methods, protocols, method/equipment validation, method development/transfer and reports as required.
• Able to follow and have a detailed understanding of specifications for sample analysis.
• Provides technical support/advice and guidance for QC testing to ensure that the test methods are robust and drive improvement of test methods.
• Ensures Stability program operates efficiently and supports product shelf life to meet regulatory requirements
• Management of documentation, laboratory systems and processes to include updating as required existing.
• Required to be involved in various audits and provide responses to auditors questions for Internal and External audits.
• Experience in identifying out of specification, atypical results and trend.
• Lead/authorise Laboratory investigations, Deviations and Change control
• Can highlight potential issues rapidly to the relevant people in a clear, concise and timely manner offering solutions when appropriate;
• Seeks best practice and shares within the team and to a wider audience.
• Act as a Subject matter expert for Laboratory systems and Stability testing.
• Degree in Chemistry, Pharmaceutical Science, analytical or related
• Proven experience of 3-5 years as QC Manager or 5-7 years as Deputy Manager running QC or testing team from within the pharma.
• Strong hands-on experience of undertaking testing, analysis and development using instrumentational analysis such as HPLC, Dissolution, FTIR and GC.in a cGMP environment.
• Extensive knowledge of GMP, ICH guidelines, BP/EP/USP methods with a strong understanding of QA processes and methodologies.
• Experience of LIMS or equivalent system is desirable
• Strong Microsoft Office Suite experience
Salary £40k - £45k
Job Ref: 5121
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