Deputy Laboratory Manager

Job Description

Deputy Laboratory Manager£28,000 PermanentHours of 8.00am - 4.30pm Monday to FridayPharmaceutical industryBased in MerseysideA successful healthcare company with sites both in the UK and overseas is looking to recruit a Deputy Laboratory Manager to their site in Merseyside on a Permanent basis. Access to own transport is recommended due to location or would need to live locally.Role:As a Member of the Site Quality function and reporting directly to the QC and QA and Compliance Manager, the principal responsibility of this position is to support the QC Manager at the Manufacturing Facility, to facilitate the testing and release of manufacturedproducts with 17 direct reports across both the main QC and Raw Materials laboratories.Duties:

• Supervision of a team of analysts in the Quality Control and Raw Materials laboratories ensuring compliance with principles of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP).
• Ensuring the department complies with site and laboratory health, safety and environmental requirements.
• Liaising with Quality Assurance to prioritise the testing and release of manufactured products.
• Assigning duties to the Quality Control / Raw Materials Analysts dependant on production release requirements ensuring the laboratory operations are performed in an organised and efficient manner to prevent any delays in material/product release.
• Ensure all equipment in the Quality Control / Raw Materials Laboratories is calibrated and available for use.
• Preparation and review of Standard Operating Procedures (SOPs), Raw Material Documents, Analytical Test Reports, Validation Protocols and Reports.
• Reviewing completed analytical testing reports. Electronic review, approval and signing of chromatographic data.
• Update of raw material/finished product testing trend files.
• Perform sampling and testing of raw materials and manufactured products. Method development and validation to current ICH guidelines.
• Performing investigations into out of specification results to establish the root cause and raise appropriate CAPA actions.
• Deputise to the QC Manager in their absence.
• Provide technical support and troubleshooting and equipment and analytical methods.
• Assist in the training of analysts.
• Assist in the interface between the Raw Materials Laboratory, Quality Assurance, Purchasing and Production.
• Inspection preparation - using GMP knowledge and experience to assist department inspection readiness
• Review of analytical data against the relevant pharmacopeial and registered specifications.
• Application of knowledge & experience to support colleagues and other Departments as required
• Undertake such other reasonable duties as may be required from time to time to support the business.

Qualifications and Experience:

• Management skills and experience of managing a team of analysts.
• Experience of testing of raw materials to British Pharmacopoeia and finished products to registered specifications.
• Excellent communication skills, both verbal and written, with a passion for accuracy and attention to detail.
• Strong analytical thinking and problem solving/troubleshooting.
• Analytical experience, preferably including IR and NIR spectroscopy, High Performance Liquid Chromatography (HPLC), Gas Chromatography.
• The role owner will have proven supervisory/management experience within a Quality Control / Analytical laboratory in a Pharmaceutical manufacturing environment. It is anticipated that the person will have a minimum of three years practical experience oftesting of raw materials to British Pharmacopoeia and pharmaceutical products to registered specifications.
• A Degree in Chemical Sciences is essential.

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