Sachin, Surat, Gujarat
Not disclosed
On-site
Full Time
Job Summary: The QC Officer is responsible for sampling, analyzing, and validating raw materials, packaging materials, in-process samples, finished products, and stability samples to ensure compliance with GMP, regulatory standards, and company SOPs. Key Responsibilities: Sample Collection & Testing: Perform sampling and testing of raw materials, packing materials, and finished products as per SOPs. Conduct chemical and physical analysis using instruments such as HPLC, UV, FTIR, GC, etc. Documentation & Reporting: Maintain proper documentation (records, logbooks, and reports) in compliance with Good Documentation Practices (GDP). Prepare Certificate of Analysis (CoA) and maintain testing records. Stability Studies: Conduct stability sample analysis as per schedule and regulatory requirements. In-Process Quality Checks: Support production by performing in-process quality control checks. Calibration & Maintenance: Ensure calibration and preventive maintenance of QC instruments. Report any instrument malfunction or deviation immediately. Compliance & Audit Readiness: Follow cGMP and safety protocols strictly. Participate in internal and external audits (USFDA, WHO, EU-GMP, etc.) and support audit documentation. Deviation, OOS & CAPA Handling: Support investigations in case of OOS (Out of Specification), deviations, and implement CAPA. Key Skills & Competencies: Good understanding of cGMP, ICH, and regulatory guidelines. Proficiency in analytical instruments (HPLC, GC, UV, etc.). Strong documentation and data integrity practices. Analytical thinking and attention to detail. Effective communication and teamwork. Job Types: Full-time, Permanent, Internship Pay: ₹15,000.00 - ₹25,000.00 per year Benefits: Cell phone reimbursement Health insurance Paid sick time Paid time off Provident Fund Schedule: Day shift Morning shift Supplemental Pay: Performance bonus Work Location: In person
India
INR Not disclosed
On-site
Full Time
Job Summary: The QC Officer is responsible for sampling, analyzing, and validating raw materials, packaging materials, in-process samples, finished products, and stability samples to ensure compliance with GMP, regulatory standards, and company SOPs. Key Responsibilities: Sample Collection & Testing: Perform sampling and testing of raw materials, packing materials, and finished products as per SOPs. Conduct chemical and physical analysis using instruments such as HPLC, UV, FTIR, GC, etc. Documentation & Reporting: Maintain proper documentation (records, logbooks, and reports) in compliance with Good Documentation Practices (GDP). Prepare Certificate of Analysis (CoA) and maintain testing records. Stability Studies: Conduct stability sample analysis as per schedule and regulatory requirements. In-Process Quality Checks: Support production by performing in-process quality control checks. Calibration & Maintenance: Ensure calibration and preventive maintenance of QC instruments. Report any instrument malfunction or deviation immediately. Compliance & Audit Readiness: Follow cGMP and safety protocols strictly. Participate in internal and external audits (USFDA, WHO, EU-GMP, etc.) and support audit documentation. Deviation, OOS & CAPA Handling: Support investigations in case of OOS (Out of Specification), deviations, and implement CAPA. Key Skills & Competencies: Good understanding of cGMP, ICH, and regulatory guidelines. Proficiency in analytical instruments (HPLC, GC, UV, etc.). Strong documentation and data integrity practices. Analytical thinking and attention to detail. Effective communication and teamwork. Job Types: Full-time, Permanent, Internship Pay: ₹15,000.00 - ₹25,000.00 per year Benefits: Cell phone reimbursement Health insurance Paid sick time Paid time off Provident Fund Schedule: Day shift Morning shift Supplemental Pay: Performance bonus Work Location: In person
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