VQ Life Sciences are recruiting for a Permanent Lead Microbiology Scientist for a leading Pharmaceutical Contract Development & Manufacturing Organisation based in North Wales.
There is a position available for a Senior Microbiologist – Quality Control to join our evolving Microbiology function positioned within the Project Operations group. The role is a practical laboratory based role & will form a critical part of the business, providing an essential function to support the set-up, qualification & operation of a high performance GMP microbiology laboratory performing a wide variety of microbiological method development, method qualification and product testing. The Senior Microbiologist will report directly to the Laboratory Manager Microbiology. The role will involve interaction across various business groups such as development teams & quality assurance to deliver & maintain companies microbiology laboratory strategy.
Candidates should possess a strong background in Pharmaceutical Microbiology & preferably with anaerobic microbiological testing experience and within a Good Manufacturing Practice (GMP) arena. The ideal candidate will possess the expertise to develop new methods, transfer client’s method and optimise method performance.
A good level of attention to detail, good organisation and interpersonal skills and the ability to manage, train and mentor junior staff. The ideal candidate would be a good team player with the confidence and ability to represent the department in project meetings and to build relationship with customers, as well as being a champion of quality improvement initiatives. Critical attributes for the role are enthusiasm, pragmatism, positive attitude, as well as commitment to the role & on-time completion.
Day to day activities for the Senior Microbiologist – Quality Control include the following:
* Performing pharmaceutical microbiology testing to Good Manufacturing Practice (GMP) requirements within agreed timelines to meet business needs.
* Developing and validating analytical test methods for the testing of pharmaceutical products.
* Preparing protocols and reports for method development and validation activities, and to support in analytical investigations when required.
* Planning, performing and reporting of QC testing on time in full.
* Provision of accurate checking and signing of development write ups and analytical data, ensuring “Right First Time”.
* Effective communication with cross-functional teams including the reporting of data and project progress to project teams including participating in client calls.
* Supporting in the purchase, validation, and maintenance of equipment for the microbiology team, including the writing of URS documents where required.
* Writing and rolling review of Standard Operating Procedures (SOPs).
* Ensuring the laboratory is clean and tidy at the end of each day and participating in self inspections.
* Observing and complying with GMP and Health and Safety Policies & Procedures
* Motivating and coaching members of microbiology team.
* Identifying and delivering opportunities to improve testing efficiencies or laboratory operations.
* Review and approval of analytical methods, batch analytical records (BARs), standard operating procedures (SOPs)
* Preparation and review of user requirement specifications (URS) for laboratory equipment
* Preparation and review of QC validation protocols and reports
* Leading investigations & review of corrective and preventative actions (CAPA) completed by QC
* Preparing a rolling review of QC documentation
* Preparation and approval of certificates of analysis (CofAs) and data tables
* Preparation and review of QC reports
* Preparation and review of stability protocols
* Retention and archiving of QC records
* QC representative for QC audits
* Ensure consumable supplies maintained for testing activities from approved suppliers
If you have the relevant Lead Microbiology experience and interested in this Permanent position based in North Wales, please get in touch with Alex Prew
Product Quality Assurance
Good Manufacturing Practices
Corrective And Preventive Action (Capa)