About the role
Roles & ResponsibilitiesPerform method validation, stability sample analysis, and review of analytical data.Prepare and review documents, including specifications, Standard Test Procedures (STPs), Technical Data Sheets (TDS), Standard Operating Procedures (SOPs), Certificates of Analysis (COA), Method Validation Protocols (MVP), Method Validation Reports (MVR), and Method Transfer Reports (MTR).Coordinate with vendors for external calibration and collaborate with QC personnel for in-house calibration and verification of laboratory instruments and equipment.Manage QC materials, including chemicals, standards, kits, and consumables.Maintain and manage laboratory equipment and instruments.Conduct analyst qualifications and provide training to QC employees.Initiate, investigate, and track Quality Management System (QMS) activities.Ensure QC lab compliance with current Good Manufacturing Practices (cGMP).
Educational QualificationsM.Sc., M.Pharm, or a Masterís degree in Biotechnology or relevant subjects.
ExperienceHands-on experience in techniques such as CEX-HPLC, SE-HPLC, ELISA, and Capillary Electrophoresis analysis.5-8 years of relevant experience.
Soft Skill CompetenciesProficient in computer skills, including MS Word and PowerPoint.