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SalaryIntroduction to role
Required for 18 month fixed term contract
Introduction
To undertake the chemical and biochemical 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 raw materials, water and product testing where appropriate. To ensure that work performed within the laboratories is carried out in compliance with corporate statutory health and safety requirements.
Key Responsibilities
- Operate the QC Analytical Services 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 cGMP Communicate progress and escalate issues to line manager and/ or senior analyst
- Plan and complete assigned tasks within the required timeframe
- Responsible for testing raw materials, in-process, finished product and stability samples to ensure that they meet approved specifications
- Verify analytical raw data and release results from the QC Analytical 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 developments
- 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
- Current, valid Right to Work in the UK
- Degree or equivalent qualification in Chemistry/Biochemistry or other related subject or previous relevant experience
- Working Knowledge/Experience of cGMP
- Working Knowledge/Experience of the EP and USP
- Previous experience of working in a similar position as a bench analyst following written instructions and comparing analytical results with set specifications
- Experience using standard analytical laboratory equipment such as pH meters, balances, pipettes
- Good basic computer skills and literacy
