- Sampling and testing of raw materials in-process materials, finished and stability products.
- Assist at a technical level in out of specification investigation and non-conformance management.
- Participate in lab process validations, cleaning validations and equipment qualification.
- Participate in site validations for the process.
- Involved in ensuring that the laboratory is compliant to regulatory systems.
- Sampling and testing of materials, utilities and environment.
- Ensure all operations are conducted in accordance with GMP's and good scientific principles.
- Manage documentation and equipment maintenance systems within the laboratory.
- Review chemical analysis data of raw materials, in process and finish products and assess the results and action as appropriate.
- Control and management of stability activities including the monitoring of stability chambers.
- Provide product support by completing line clearances.
- Involved in updating documents within the site
- Support quality aspects of materials management including supplier approval, supplier complaints and specification management
- Degree in Chemistry with 5 years' experience in a laboratory environment
- Minimum 1 to 2 years' experience in a regulated pharmaceutical/medical device environment desirable
- Experience of method validation and method transfer
- Familiarity with OOS management required.
- Validation experience within a laboratory
- Stability experience desirable
- Experience in the use of HPLC, GC, FTIR, UV, TOC etc. as well as classical wet chemistry analyses
- Full understanding of the requirements of the Regulatory Standards
- Good communication skills
- Self-starter, highly motivated with the ability to prioritize
- Ability to work on own initiative
- Experience in using Microsoft Office products
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.