Principal QC Analyst - Microbiology

Join to apply for the Principal QC Analyst – Microbiology role at MT Consulting Group .

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 the Pharmacy Technical Services (PTS) Department is responsible for confirming pharmaceutical products are manufactured to GMP requirements and fully tested to release specifications 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 (PQS). These 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, MERs (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 MERs and LIRs 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 licensed 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.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Quality Assurance

Industries

Operations Consulting

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