To support Product Development and Commercial Supply activities by ensuring all analytical methods are developed, validated and transferred as per ICH and GMP requirements, and that all product testing is completed accurately and precisely.
- Creation and review laboratory protocols.
- Solve technical and scientific analytical problems.
- Method transfer activities.
- Cleaning method development and validation.
- Guaranteed that technical transfer analytical tasks were accomplished within the timeframes defined by the technical transfer team.
- Analytical support to all projects; activities related to analytical development, validation and/or transfer work for projects.
- Implementation of continuous improvement practices (Kaizen)
- Successful FDA audit and customer audit outcomes through proactive engagement and team work.
- Travel and collaboration between facilities to achieve successful analytical transfers.
- Successful completion of ICH guidelines 2 day training course.
- Liaised with customers to ensure project timelines were on target and any issues were addressed.
- Technical support and guidance for the QC and IPC teams for new analytical methods and techniques
- Conduct and document laboratory investigations.
- Peer review of laboratory data and evaluation of results against specification acceptance criteria.
- Sourcing and purchasing of analytical equipment, reference standards and reagents through SAP.
Skills and Experience Required:
- Qualified to a minimum of degree level.
- At least two years experience working in a related technical environment.
- 5+ year's relevant experience in GMP Manufacturing/Testing environment in the Pharmaceutical Industry.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.