An exciting opportunity has arisen for a QC Analyst to join QC In Process Control team, based in a newly 5S certified analytical laboratory. The role offers excellent exposure across both Drug Substance and Drug Product manufacturing, in a fast paced, highly compliant GMP environment.
Requirements
- Perform primary review of QC raw data and trend results
- Prepare protocols, summaries, and reports, including documents submitted directly to pharmaceutical regulatory agencies
- Draft and update QC Standard Operating Procedures (SOPs)
- Act as a technical subject matter expert (SME) and provide training and support to other analysts in areas of expertise
- Evaluate analytical and microbiological results against defined acceptance criteria
- Conduct and document laboratory investigations through to completion
- Maintain the laboratory in a constant state of audit and inspection readiness
- Interact directly with regulatory agency inspectors during audits and inspections
- Interface with other functions including Manufacturing, Quality Assurance, Facilities, and external contractors as required
Benefits
- Permanent contract of employment
- Exposure to working in Top Pharmaceutical client sites in a diverse-cultural work setting
- Employee Value Proposition: Learning & Development in-house training, mentorship, and career progression