Qc Microbiologist

3 weeks ago


Salisbury, United Kingdom Porton Biopharma Full time

**Introduction to role**:
To undertake microbiological analyses to support the manufacture of PBL’s licensed pharmaceutical products as required by EU Directive 91/356/EEC for GMP compliance. To write quality documentation relating to microbiological testing. To ensure that work performed within the laboratories is carried out in compliance with corporate statutory health and safety requirements

**Main Duties & Responsibilities**:

- Operate the QC Microbiology Laboratory in compliance with Porton Biopharma’s safety policy and cGMP
- Ensure analysis, recording of tests and interpretation of data have been performed in compliance with Communicate progress and escalate issues to line manager and / or senior microbiologist.
- Plan and complete assigned tasks within the required timeframe
- Responsible for microbiological testing of samples to ensure that they meet approved specifications.
- Undertake identification of micro-organisms isolated from microbiological tests and samples
- Prepare Environmental Monitoring consumables for Production areas and perform Environmental Monitoring when required
- Maintain the culture collection, media stocks and necessary consumable supplies to ensure the efficient running of the Unit during normal production activities
- Pre-test media used within QC and Production against pre-set specifications
- Verify analytical raw data and release results from the QC Microbiological department as appropriate
- Write SOPs, protocols, reports and risk assessments as appropriate.
- Write quality records such as non-conformances, and devise CAPAs and change controls as appropriate.
- Liaise with external testing laboratories to arrange correct and timely testing.
- Work collaboratively with team to ensure business, regulatory and customer needs are met
- Maintain an up-to-date awareness of regulatory and scientific
- Perform housekeeping of laboratories.
- Receive samples into the lab from internal and external customers
- Ensure all equipment within the QC department is calibrated and serviced
- Identify improvements

**Personal Specification - Refer to Job Description**:

- A current, valid Right to Work in the UK
- A good standard of written and spoken English Language
- HND or equivalent qualification relevant to the post


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