QC Manager - Chemistry - Pharmaceuticals - £40k-£45k- Berkshire

Employer
Location
Berkshire, United Kingdom
Salary
£40000 - £45000/annum
Posted
Dec 05, 2017
Closes
Jan 05, 2018
Ref
207008904
Contract Type
Full Time
Job Type
Lab Manager
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. Duties: * 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. Experience: * 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 Additional Experience * Strong Microsoft Office Suite experience