A major Pharmaceutical service organisation based in Swindon, Wiltshire. Across 30+ sites worldwide, the company offers a range of drug development, manufacturing, packaging and distribution services to the global pharmaceutical and biotechnology industries. The Swindon site is a R&D and manufacturing facility, producing both large and smaller quantities of patented products, including some sterile processing. This is an excellent environment in which to gain new experiences and develop your skills.
This is a challenging and engaging QC position which will suit someone with a degree and some commercial GLP experience. You will undertake the following:
- Conduct Finished Product QC release testing as required by the role with daily supervision as required using techniques such as Balances, pH meter, UV, Karl Fisher, FT-IR, TLC, Dissolution and HPLC (to include degradation analysis).
- Generate a simple test plan for a validation project.
- Write stability reports based on the protocol and test results generated.
- Entering and checking results on LIMS.
- Qumas; printing documents, and creation of basic CR’s.
- Understand and correctly implement written instructions with below the average number of method deviations.
- Perform analytical work with average testing volumes/output whilst generating data with no more than the average laboratory notebook Right First Time error rate and no less than the average analytical Right First Time as a result of human error.
- Manage day to day tasks with minimal supervision/guidance:
- Identify correct specifications and methods for testing, including stability and validation protocols.
- Complete allocated task in time frame provided and have awareness of the wider team and support peers as required.
- May plan own workload in conjunction with Senior Scientists
- Identify laboratory out of specification and out of trend results.
- Perform preliminary investigations of basic deviations and complete investigation FM022 forms.
- Complete laboratory rotas as required.
- Understand and implement lab ordering processes via VMI and Kanban systems.
- Maintain personal and communal laboratory areas in line with 5S principles.
The successful candidate will have a strong Chemistry education (BSc or MSc / MChem). You also will need to have experience in analytical testing using chemistry techniques such as HPLC, Karl Fisher, FT-IR, Balances, pH meters within a pharmaceutical QC laboratory following GLP / GMP regulations. You will also need to demonstrate the ability to take on considerable accountability to perform and complete investigations of deviations.
You will ideally be able to start at short notice and be happy to work on a contract basis for a year, with the potential for extension beyond this.
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