Roles and Responsibilities Conduct BMR reviews, CAPAs, Change Controls, GMP compliance audits, and QMS system validation. Ensure adherence to CGMP guidelines and maintain accurate records. Collaborate with cross-functional teams to resolve quality issues and implement corrective actions. Develop and execute test plans for API products in accordance with cGMP requirements. Internal audit preparation and regulatory audit support Control & review of master documents and controlled copies Desired Candidate Profile M.Pharma degree from a recognized institution (Any specialization). MS/M.Sc(Science) degree in Chemistry or related field. 2-4 years of experience in Quality Assurance department of an API manufacturing company.
Role & responsibilities Routine analysis using HPLC and GC independently Method execution, system suitability, and troubleshooting Analysis of RM/Intermediates/Finished Products Calibration & maintenance of HPLC/GC instruments Review of chromatographic data, audit readiness, and documentation Preparation of COA, STPs, and analytical records Ensuring strict compliance to cGMP and data integrity Preferred candidate profile 3+ years QC experience in an API manufacturing unit Strong hands-on expertise with HPLC & GC (operation, troubleshooting, calibration) Good understanding of ICH Q2 , cGMP, and data integrity principles Experience in routine analysis of RM/Intermediates/Finished Products Ability to interpret chromatograms and prepare analytical reports Familiar with COA/STP/SOP documentation practices Comfortable working in a fast-paced, audit-driven QC environment Education: M.Sc (Chemistry) Strong attention to detail with a disciplined work approach Willing to work in Rajkot, Gujarat Team player with good communication and accountability