0 - 5 years

0 Lacs

Kamrej, Surat, Gujarat

Posted:1 month ago| Platform: Indeed logo

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Skills Required

qc analysis test spectrophotometer sampling labeling storage calibration stability data report manufacturing compliance audits controls archiving training microbiology biotechnology regulations documentation communication software lims erp metrics testing audit schedule

Work Mode

Work from Office

Job Type

Full Time

Job Description

Key Responsibilities:Quality Control (QC): βœ… Conduct analysis of raw materials, in-process samples, and finished products using approved test methods. βœ… Operate laboratory instruments (e.g., HPLC, UV spectrophotometer, FTIR) as per SOPs. βœ… Ensure proper sampling, labeling, and storage of materials and retain samples. βœ… Maintain calibration and qualification records of lab instruments. βœ… Conduct stability studies and maintain related data. βœ… Review and approve test results; report deviations or non-conformances. βœ… Manage laboratory reagents, reference standards, and consumables. Quality Assurance (QA): βœ… Review and approve batch manufacturing and packing records (BMR/BPR). βœ… Oversee compliance with GMP, SOPs, and regulatory requirements. βœ… Coordinate and participate in internal audits, vendor audits, and regulatory inspections. βœ… Handle deviations, change controls, CAPA (Corrective & Preventive Actions), and complaint investigations. βœ… Manage document control: issuance, review, and archiving of SOPs, policies, and records. βœ… Conduct training for plant personnel on quality systems and GMP. βœ… Perform periodic review and qualification of equipment, processes, and cleaning validation. Required Qualifications: Education: B.Sc. / M.Sc. in Chemistry, Microbiology, Biotechnology, or B.Pharm / M.Pharm Experience: 2–5 years in QC/QA within the pharmaceutical or nutraceutical industry Key Skills and Competencies: Strong knowledge of nutraceutical regulations (FSSAI, WHO-GMP, USFDA, etc.) Hands-on experience with analytical techniques and equipment Excellent understanding of documentation practices and quality systems Good communication and interpersonal skills Attention to detail, problem-solving ability, and proactive approach Familiarity with software like LIMS, ERP, or electronic documentation systems (if applicable) Performance Metrics: Compliance rate with regulatory and internal standards Accuracy and timeliness of testing and documentation Number of deviations, CAPAs, and their timely closure Successful audit outcomes (internal and external) Training compliance of plant personnel Job Type: Full-time Pay: β‚Ή15,000.00 - β‚Ή30,000.00 per month Benefits: Paid sick time Schedule: Day shift Supplemental Pay: Yearly bonus Work Location: In person

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