J4977CheshirePharmaceutical PermanentFull Time09/01/2018Chemistry - Quality Control
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Job Description Quality Control Manager
Role Overview: The Quality Control Manager will organise and manage the day to day operations of the Pharmaceutical QC testing laboratory. Responsible for managing the delivery and execution of raw material testing, component testing, finished product testing and stability testing as part of the Quality Organisation. There is an emphasis on metred dose inhalers, nasal delivery and topical creams. This is an exciting time to join the organisation as there is an increasing number of key projects already within the group and a number within the pipeline, with the company ambition to be a leader in its field.
Key Duties and Responsibilities This position will be responsible for both the management and delivery of QC testing across all projects
Technical To lead the analytical testing for all approved, commercial products including method development/transfers and stability testing. Additionally, this role will be responsible for equipment maintenance, calibration and all equipment validation activities across the laboratories.
Customer Service To deliver high quality analysis and documentation to meet the commercial timelines.
People To lead and develop staff within the team to reach the required performance and competency levels.
Quality To ensure the correct GMP standards are followed, take responsibility for fronting internal and external QC audits.
Safety To ensure that all site safety standards are followed and that staff are fully trained to undertake the tasks assigned to them.
Documentation To write, review, approve and implement SOPs, methods, specifications, validation documents, protocols and reports as required. Additionally this role will be required to manage any quality incidents in the QC laboratory.
Peer Relationships To build and maintain key relationships within the quality team, the regulatory team and the operations team.
Continuous Improvement Will drive improvements throughout the QC laboratory to ensure test methods are robust to drive quality and speed.
This role will report to a Head of Quality.
Role Requirements: The Quality Control Manager can demonstrate more than 5 years' experience within a QC laboratory and a minimum of 2 years in a leadership role. Strong, hands on experience of HPLC, Raw materials and managing stability testing. Extensive knowledge of GMP, ICH guidelines, BP/EP/USP methods and a strong understanding of QA processes and methodology. A degree in chemistry, Pharmaceutical Sciences or related would be preferred