Senior Executive - Quality Control
About the Employer
Job Description
WE'RE HIRING!
Senior Executive – Quality Control
A reputed pharmaceutical organization based in Sri Lanka.
Location: Ja- Ela, Sir Lanka
Key Responsibilities:
- Establish and maintain a comprehensive NABL / ISO 17025:2017 Quality Manual, SOPs, and quality records in line with accreditation requirements.
- Ensure metrological traceability of measurement results and proper estimation of measurement uncertainty.
- Successfully participate in relevant Proficiency Testing (PT) programmes prior to accreditation for each applicable discipline.
- Perform routine testing of raw materials, excipients, packaging materials, water, and finished pharmaceutical products.
- Prepare and maintain Certificates of Analysis (COA), Specifications, STPs, and SOPs.
- Conduct and support investigations related to OOS, OOT, incidents, and deviations.
- Review routine analytical data, stability data, specifications, and test procedures.
- Perform analytical method development and validation, including preparation of AMV protocols and reports.
- Analyze formulation development trials, stability samples, and drug-excipient compatibility samples.
- Perform assay, related substances, and dissolution testing using HPLC and UV instruments.
- Execute analytical development using HPLC and GC.
- Conduct water-content testing and identification testing using IR instrumentation.
- Review laboratory documentation and support the release of materials.
- Perform calibration and verification of analytical instruments and conduct stability sample analysis.
- Ensure laboratory activities are carried out in compliance with GLP, cGMP, QC procedures, and regulatory requirements.
Requirements:
- BSc in Chemistry or equivalent qualification.
- Minimum 5 years of relevant experience in a pharmaceutical manufacturing QC laboratory or a similar regulated laboratory environment.
- Sound knowledge of NABL / ISO 17025:2017, GLP, cGMP, analytical testing, and laboratory documentation.
- Hands-on experience with analytical instruments including HPLC, GC, UV, and IR.
- Experience in analytical method development, validation, stability testing, and investigation procedures will be highly valued.
- Strong attention to detail, documentation skills, analytical capability, and commitment to quality standards.
Compensation & Benefits:
Competitive salary package and ability to work flexible hours, split shifts, weekends, and public holidays when operationally required.
Please indicate your expected salary when applying.
Apply Now:
Phone: 077-5900566
Email: [email protected]
