Thane, Maharashtra
INR 0.3 - 0.4 Lacs P.A.
On-site
Full Time
Key Responsibilities: 1. Documentation & Compliance Ensure GMP (Good Manufacturing Practices) and AYUSH guidelines are strictly followed. Maintain and review Standard Operating Procedures (SOPs) , Batch Manufacturing Records (BMR), and Batch Packing Records (BPR). Manage change control, deviation reports, CAPA (Corrective and Preventive Actions), and risk assessments. Maintain updated regulatory documents as per FDA, AYUSH, and ISO requirements. 2. Batch Release & Review Ensure line clearance before manufacturing and packaging activities. Review batch records and ensure compliance before batch release. Verify in-process quality control (IPQC) and coordinate with production for real-time corrections. 3. Audits & Inspections Prepare and face internal, external, and regulatory audits (FDA/AYUSH/ISO). Ensure timely closure of audit observations and prepare audit reports. 4. Training & Development Conduct GMP training programs for production, QC, and warehouse staff. Ensure all employees are updated with current quality standards and practices . 5. Supplier & Material Quality Management Review and approve vendor qualifications , raw materials, and packaging materials. Maintain raw material specifications and conduct periodic vendor audits. 6. Quality Risk Management Conduct root cause analysis (RCA) for deviations and complaints. Lead CAPA implementation and ensure product safety and efficacy . 7. Product Quality & Market Complaints Monitor product stability and conduct trend analysis. Investigate and report market complaints and product recalls if required. 8. Coordination with Other Departments Coordinate closely with Production, QC, R&D, and Warehouse teams. Support New Product Development (NPD) by ensuring documentation and quality compliance. Desirable Skills & Knowledge: Knowledge of Ayurvedic formulation standards . Familiarity with Schedule T , AYUSH guidelines, and GMP norms. Attention to detail, leadership, and strong communication skills. Proficient in MS Office and QMS software. Job Type: Full-time Pay: ₹30,000.00 - ₹40,000.00 per month Benefits: Provident Fund Schedule: Day shift Work Location: In person
Ambernath, Thane, Maharashtra
INR 0.3 - 0.4 Lacs P.A.
On-site
Full Time
Key Responsibilities: Quality System Management: Oversee implementation and maintenance of Quality Management System (QMS). Monitor compliance with cGMP guidelines, SOPs, and regulatory requirements. Documentation & Record Review: Approve and control SOPs, batch records (BMR/BPR), validation protocols, and reports. Review and release of finished product batches after thorough documentation check. Audit Handling: Lead internal and external audits (Regulatory, Customer, Third-party). Prepare audit readiness plans and ensure timely closure of audit observations with CAPA. Deviation, OOS, and CAPA Management: Review and approve deviation reports, OOS investigations, and root cause analysis. Ensure effective implementation and monitoring of CAPAs. Validation & Qualification Oversight: Supervise and approve process validation, cleaning validation, equipment qualification. Review validation master plan and coordinate with concerned departments. Training & Compliance: Develop and execute training programs on GMP, documentation practices, and quality compliance. Maintain training records and ensure staff competence. Change Control & Risk Management: Evaluate and approve change controls, risk assessments, and impact analysis on quality. Promote quality risk management throughout the facility. Team Leadership: Guide and supervise the QA team. Ensure team productivity, skill enhancement, and performance management. Job Type: Full-time Pay: ₹30,000.00 - ₹40,000.00 per month Benefits: Provident Fund Schedule: Day shift Work Location: In person
Thane, Maharashtra
INR 0.15 - 0.22 Lacs P.A.
On-site
Full Time
Key Responsibilities: Documentation & Record-Keeping: Maintain and review SOPs, BMRs, BPRs, change control documents, and other QA-related documents. Ensure Good Documentation Practices (GDP) are followed. Compliance & Audits: Conduct internal quality audits and prepare CAPA reports. Assist in regulatory and customer audits (USFDA, MHRA, WHO, etc.). Ensure compliance with cGMP, GLP, and other regulatory requirements. Deviation, CAPA, & Change Control: Investigate deviations and OOS (Out of Specification) incidents. Initiate and monitor Corrective and Preventive Actions (CAPA). Manage change control documentation and impact assessment. Batch Release & Review: Review completed batch records and analytical data before batch release. Participate in decision-making for batch disposition. Training & Awareness: Conduct or coordinate GMP training for production and quality teams. Maintain training records and assess training effectiveness. Validation & Qualification: Support in process validation, cleaning validation, and equipment qualification activities. Review validation protocols and reports. Continuous Improvement: Participate in Quality Risk Management (QRM) initiatives. Suggest improvements to enhance product quality and process efficiency. Job Type: Full-time Pay: ₹15,000.00 - ₹22,000.00 per month Benefits: Provident Fund Schedule: Day shift Work Location: In person
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