Our client is looking to recruit a Senior QC Analyst to join their growing team.
The chosen candidate will:
Analytical Testing & Reagent Preparation
- Prepare, standardize, and label stock solutions, volumetric solutions, and laboratory reagents according to standard operating procedures (SOPs).
- Perform routine and non-routine testing on finished products and purified water using approved Pharmacopoeial and internal analytical methods and specifications.
- Utilize advanced chromatographic techniques (e.g., HPLC/UPLC, GC) for quantitative and qualitative analysis.
Equipment Qualification & Maintenance
- Ensure the proper handling, routine maintenance, qualification, and calibration of analytical laboratory equipment.
- Support external contractors and service engineers during equipment servicing, qualification, and calibration visits.
- Maintain complete and accurate equipment calibration and maintenance records in accordance with cGMP guidelines.
Quality Compliance & Documentation
- Maintain, update, and review QC documentation, including SOPs, test methods, analytical logs, and laboratory registers to ensure ongoing regulatory compliance.
- Execute Good Documentation Practices (GDP) across all analytical testing records and raw data reports.
Investigations & Team Mentorship
- Support and participate in QC analytical investigations, including Out-of-Specification (OOS), Out-of-Trend (OOT), and Out-of-Expectation (OOX) results.
- Assist in logging, investigating, and resolving laboratory deviations, CAPAs, and change controls.
- Provide technical guidance, training, and operational support to junior QC analysts where required.
- Carry out other Quality Control duties as assigned by the QC Manager.
Requirements
- Excellent precision and accuracy in laboratory testing and record-keeping.
- Strong task prioritization, time management, and multi-tasking skills in a fast-paced laboratory setting.
Education and experience
- Minimum of 3 years of hands-on experience in a pharmaceutical Quality Control (QC) laboratory environment.
- Demonstrated proficiency in chromatographic techniques (HPLC, GC) and laboratory software systems.
- Solid understanding of EU Good Manufacturing Practice (cGMP), GDP, and pharmacopoeial guidelines.
- Excellent verbal and written communication skills in English.
- Degree or Diploma in a scientific discipline (e.g., Chemistry, Pharmaceutical Science, Biology, or a related field).