Microbiologist - Sterile Pharmaceuticals
Competitive Salary + Excellent Benefits
Do you have significant experience in QC Microbial testing of sterile pharmaceutical products?
Would you like to work for a leading pharmaceutical drug development organisation in the London area?
My client are a successful CRO, providing translational drug discovery and drug development expertise, working in partnership with some of the leading global pharmaceutical and biopharmaceutical companies. Due to continued growth they are looking to hire a Microbiologist to perform and provide support and expertise in the sterility testing of produced compounds and for the environmental monitoring of conditions within the production and QC areas. The Microbiologist will ensure compliance to relevant standards involved in the production and aseptic manipulations of sterile products.
The London site is involved in the development and manufacture of compounds for intravenous injection into patients/volunteers as part of clinical programmes. The Microbiologist principal accountabilities are to perform and provide support and expertise in the sterility testing of products and for the environmental monitoring of conditions within the Quality Control (QC) and Production areas.
The company Microbiologist will be responsible for;
* Ensuring day-to-day running of Microbiology laboratory
* Performing in-house sterility testing on manufactured products and managing contractor companies for outsourced microbiological testing
* Monitoring and trending of microbiological data
* Documenting microbiological records to ensure compliance with cGMP.
* Regularly reporting of results and summaries of own work to line manager.
* Responsible for microbiological test implementation of new compounds: method development, validation and documentation.
* Execution of Media Fills & protocols required as part of sterile process assurance
* Performing routine QC testing to support clinical and pre-clinical studies when required.
Investigations of out of specifications/atypical results obtained from microbiological testing
* Keeping procedural documents and policies on Environmental Monitoring relevant and up to date with Regulation guidelines.
* Leading site compliance and remedial activities in microbiologically related areas
* Validation and Qualification of Isolators Gassing Cycles
* Monitoring of water systems used in product manufacture
* Presenting technical microbiological issues and results to internal and external audits
* Continuous improvement of the sterile process assurance.
* Training new members of staff in microbiology related activities
* Line management responsibility for a Laboratory Technician
To be considered for this position you will have the following skills and experience;
* A BSc/MSc Degree or equivalent in a relevant field such as microbiology, pharmaceutical science, biochemistry, cell biology, applied biology or a related subject
* Significant experience of working in microbiology, specifically supporting sterility testing and environmental monitoring activities
* Ideally experience investigating out of spec results and implementing CAPAs
* Good understanding of GMP and ability to front external audits
* Good Microsoft Office skill
* Excellent Communication and Team working skills
Please apply online or call Neil Walton on 02030964706 for further information.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.
You must be eligible to work in the UK. Learn more
- Agency: SRG
- Reference: J29837
- Posted: 11th March 2019
- Expires: 8th April 2019