Senior QC Analyst
This is Ideal for Candidates with Strong Experience in Analytical Data Review, Laboratory Coordination, GMP Compliance and QC Planning Activities
ROLE
* Review Analytical Data Generated from QC Testing
* Coordinate and Support QC Laboratory Testing Schedules and Planning Activities
* Review Analytical Data from HPLC, UV, FTIR, and Karl Fischer Testing
* Ensure Compliance with ALCOA++, Data Integrity, and GMP Requirements
* Support Laboratory Investigations, Including OOS, OOT, Deviations, and CAPA’s
* Review Laboratory Documentation In-Line with Quality and Regulatory Standards
* Support Method Validation and Verification Activities
* Ensure Compliance with ICH Guidelines and CFR Requirements
* Work Collaboratively with Other Site Departments
* Support Continuous Improvement Initiatives within the QC Function
REQUIRED
* Degree in Chemistry, Pharmacy, or Related Scientific Discipline
* 5–10 Years’ Experience within Quality Control in a Pharmaceutical or Highly Regulated Laboratory Environment
* Strong Experience Reviewing Analytical Data and Regulatory Compliance
* Hands-on knowledge of HPLC, UV, FTIR, and Karl Fischer analysis
* Solid Understanding of GMP, Data Integrity, and Regulatory Compliance
* Experience with Laboratory Software Systems such eg Chromeleon or Similar
* Strong Organisational Skills with Ability to Prioritise QC Activities
* Excellent Attention to Detail
* Experience with OOS/OOT Investigations and Deviation Management
* Exposure to Method Validation and Method Transfer Activities