0 years

0 Lacs

Thane, Maharashtra

Posted:2 days ago| Platform:

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Skills Required

Microsoft Office In-person Communication skills

Work Mode

On-site

Job Type

Full Time

Job Description

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

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