QC Analytical Specialist - Method Development
GlaxoSmithKline View all jobs
- Cork
- Permanent
- Full-time
- Be a subject matter expert for a subset laboratory techniques and processes
- Investigative analysis to support troubleshooting and root cause investigations in support of customer sites across the supply chain
- Support and lead analytical method development, validation and transfer
- Support the review and approval of completed testing
- Partake and sometimes lead laboratory investigations and root cause analysis
- Ensure all activities are completed in line with current GMP, Data Integrity and Safety standards
- Support the ongoing implementation of quality, compliance and safety standards (internal audits, risk assessments etc.)
- Support the development and implementation of lean standards to drive operational efficiency within the laboratory
- Routine QC testing in compliance with registered details and pharmacopeial requirements
- Support the training and capability build of fellow analysts
- Relevant science degree, preferably in chemistry or a demonstrated track record in the pharmaceutical industry in a technical focused quality role
- Experience in regulated pharmaceutical quality laboratory
- Proficient in a range of analytical techniques
- Excellent analytical problem-solving skills
- Proven ability to work under own initiative and as part of a team to meet targets
- An understanding and experience of analytical testing of APIs, drug products, excipients and raw materials, and the associated analytical techniques including, but not limited to HPLC, LC-MS, GC, ICP, particle size testing.
- An understanding of method validation and transfer requirements.
- LC-MS experience
- MSc or PhD in Chemistry or equivalent and/or an extensive demonstrated track record in the pharmaceutical industry in a technical focused quality role.