This role involves monitoring in-process quality checks in the manufacturing area API to ensure compliance with cGMP SOPs and regulatory requirements The role involves real-time verification of manufacturing activities documentation review and effective communication with production and QA teams Key ResponsibilitiesEnsure adherence to cGMP and GDP practices during all in-process activities Perform line clearance checks before starting production and packaging operations Monitor and verify critical manufacturing and packaging parameters as per approved BMR BPR Review and ensure compliance with SOPs protocols and regulatory guidelines Verify sampling labeling and dispensing of raw materials and intermediates Perform in-process checks and record observations in real-time Ensure timely identification documentation and escalation of any deviations OOS OOT or incidents Support QA team in investigations and CAPA implementation Participate in internal audits regulatory inspections and compliance activities Maintain effective communication with Production QC and QA teams for smooth operations Ensure that all activities are performed safely and in accordance with company policies Skills CompetenciesStrong knowledge of cGMP GDP and regulatory compliance Hands-on experience in API manufacturing processes Good understanding of QA QC procedures Robust communication and interpersonal skills for cross-functional coordination Documentation accuracy and attention to detail Ability to work in a fast-paced manufacturing environment Qualification M Sc Chemistry Pharmaceutical Sciences Experience 2 to 4 Years API industry experience mandatory Additional ResponsibilitiesConduct periodic shop floor rounds to ensure compliance with cGMP and safety practices Provide on-the-job training to production personnel on documentation and quality practices Support preparation and review of SOPs protocols and batch records Monitor and control environmental conditions in production areas temperature pressure differentials cleanliness Ensure timely closure of deviations CAPA and change controls related to IPQA activities Support technology transfer and validation activities from a QA perspective Assist in review of batch manufacturing records BMR and batch packaging records BPR for completeness and compliance Act as QA representative during regulatory and customer audits Contribute to continuous improvement initiatives in QA and manufacturing processes