QC Manager, Pharmaceutical

1 month ago

Westhoughton Greater Manchester, United Kingdom Crescent Pharma Ltd Full time

Crescent Medical (a subsidiary of the Crescent Pharma group) are currently recruiting for a Pharmaceutical QC Manager to join our team making generic solid dosage medicine for the UK Pharmaceutical market based at our site in Bolton. The selected candidate will be required to work within a small but growing team to execute the management teams plan to set up our QC lab and gain MHRA approval for on site testing. The ideal candidate will take a hands-on approach in their work, be experienced working with growing teams and have experience working in a GMP environment. Start date would be immediate and the role will be permanent.

Role Expectation

* To build, direct and manage the QC department through leadership, education and continuous improvement

* Manage the QC team once hired to deliver a GMP, GCLP compliant and efficient service with focus on product safety and value added activity.

* To provide the required QC technical knowledge, support and guidance across the business.

Main responsibilities:

* Ensure compliance with the health, safety and environmental management systems, regulations and associated procedures

* Manage the testing of raw materials, packaging components, process intermediates and finished products including stability samples.

* Ensuring testing is performed on time in accordance with business need and that all testing is in compliance with EU GMP and compendial requirements

* Manage all laboratory activities via effective work scheduling and establishing priorities

* Monitor, maintain and develop GMP and GCLP standards within the QC department including compliance with data integrity.

* Ensure practices, processes and procedures are simple, risk based, robust and compliant

* Coordinate OOS/OOT/OOE investigations for effective root cause analysis and CAPA within the required timescales

* Participate in assessment and audit of relevant third parties as required

* Manage continuous improvement activities within the laboratory

* Assist in new product development by recommending and/or establishing the necessary quality control requirements.

* Manage all laboratory equipment service/calibration & qualification activities and third party service contracts in accordance with GMP/GCLP requirements

* Design, review and approve documentation in accordance with GMP including but not limited to standard operating procedures (SOPs), test methods, specifications, worksheets, batch analytical records, validation documentation, protocols & reports.

* Perform the review, checking and QC approval of batch documents where necessary

* Manage the provision of QC data for annual product quality reviews

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