Senior QC Analyst

Our Client, Located Near to Wellingborough, are Seeking an  Experienced Senior QC Analyst to join their Pharmaceutical Quality Control Laboratory Team, who are Responsible for Performing Analytical Testing, Conducting Investigations, and Ensuring Regulatory Compliance

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