Key Responsibilities
- Develop, implement, and maintain the Quality Assurance system in compliance with AYUSH, GMP, GLP, and applicable regulatory guidelines.
- Review and approve Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), specifications, protocols, and validation documents.
- Approve or reject raw materials, packaging materials, in-process materials, and finished products based on quality standards.
- Monitor manufacturing activities to ensure adherence to approved procedures and quality standards.
- Handle deviations, change controls, non-conformances, Out-of-Specification (OOS) investigations, CAPA, and risk assessments.
- Plan and conduct internal quality audits and ensure timely closure of audit observations.
- Coordinate regulatory inspections and customer audits, ensuring compliance with all observations.
- Review and monitor validation and qualification activities, including process validation, cleaning validation, equipment qualification, and utility validation.
- Oversee stability studies, product quality reviews (PQR/APQR), and annual quality assessments.
- Ensure proper documentation practices (GDP) and data integrity across all quality records.
- Investigate customer complaints and coordinate product recalls whenever required.
- Lead, mentor, and develop QA personnel through regular training and performance evaluations.
- Coordinate with Production, QC, R&D, Purchase, Warehouse, and Regulatory Affairs for quality-related activities.
- Ensure calibration schedules, environmental monitoring, and sanitation programs are effectively implemented.
- Drive continuous improvement initiatives to enhance product quality, compliance, and operational efficiency.
Qualification
- Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm), Ayurveda (BAMS), Chemistry, Microbiology.
- Additional certification in GMP, Quality Management, or Regulatory Affairs will be an added advantage.
Experience
- 4–6 years of experience in Quality Assurance within an Ayurvedic, Herbal, or Pharmaceutical manufacturing company.
- Thorough knowledge of AYUSH guidelines, GMP, GLP, documentation practices, validation, and quality systems.
Required Skills
- Strong leadership and team management skills.
- Excellent knowledge of Quality Management Systems (QMS).
- Expertise in GMP, GLP, AYUSH regulations, and Schedule T.
- Strong analytical and problem-solving abilities.
- Excellent documentation and report-writing skills.
- Good communication and interpersonal skills.
- Proficiency in MS Office and ERP/QMS software.
Pay: ₹30,000.00 - ₹45,000.00 per month
Benefits:
- Leave encashment
- Paid sick time
- Paid time off
- Provident Fund
Ability to commute/relocate:
- POR, Vadodara, Gujarat: Reliably commute or planning to relocate before starting work (Required)
Experience:
- QA Department: 4 years (Required)
Work Location: In person
