Principal QC Analyst - Microbiology

at  London North West University Healthcare NHS Trust

This post is to provide direct support to the Quality Department in the management of the day-to-day aspects of the Quality Control Laboratory to ensure adherence to established quality standards. The Quality control section of Pharmacy Technical Services (PTS) Department is responsible to confirm pharmaceutical products are manufactured to GMP requirements and fully tested to release specification in line with all relevant regulatory standards to safeguard product quality and patient safety.
The post holder will need the combined skills of project management, data analytical skills and be able to communicate effectively with PTS team members at all levels.

Analysis, interpretation and reporting of test results of a wide range of raw materials, packaging materials, intermediates bulk and finished products as required. To supervise and direct all these activities as needed.

• To undertake and supervise stability studies – microbiological and, analytical method development and validation (ICHQ2 (R1)) of new formulations and existing products.
• Responsible for the establishment, maintenance and review of the documents supporting the Pharmaceutical Quality System (PQSThese documents include policies, standard operating procedures, protocols, worksheets, equipment maintenance records including planned preventative maintenance, full records of testing of all starting materials, packaging materials, intermediates and finished products as agreed in the PQS.
• To ensure timely closure of incident logs, deviations, change controls, MER’s (Microbial excursion reports) and CAPAs by carrying out tasks as agreed and providing evidence for the same.
• To carry out laboratory investigation and root cause analysis as needed. Provide support and direction to QC analysts and ensure review/closure of MER’s and LIR’s on time.
• Comply with data integrity policy and procedure
• Provision of microbiological trend analysis reports and potential improvements
• To act as a releasing officer for pre-pack over labelled products manufactured under MHRA ‘Specials’ licence.

The Pharmacy Technical Services Department at Northwick Park Hospital offers comprehensive pharmaceutical manufacturing services which includes a licenced ‘Specials’ manufacturing unit. The department manufactures sterile and non-sterile products under the MHRA ‘specials’ manufacturing licence. The department also provides cytotoxic and parenteral nutrition reconstitution service under section 10.
To view the main responsibility, please see the attached the Job Description and Person Specification

Please refer the Job description for details