QC Manager - Chemistry - Pharmaceuticals - £40k-£45k- Berkshire
QC Manager - Chemistry - Pharmaceuticals - £40k-£45k- Berkshire - HPLC - GC - Method Development
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
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