Location: Hyderabad, Telangana (plant location)
Experience: 17-25 Years
Qualification: B.Pharm / M.Pharm / M.Sc.
Age: Up to 50 Years
Industry: Pharmaceutical / Formulations
Function: Quality Assurance
Job Description
We are looking for a senior Quality Assurance professional to head QA activities for an established pharmaceutical manufacturing facility with a strong focus on Oral Solid Dosage (OSD) formulations.
The position requires a robust understanding of pharmaceutical quality systems, regulatory compliance and experience in managing quality operations in a highly regulated manufacturing environment.
Key Responsibilities
- Manage the complete QA function for OSD manufacturing operations.
- Ensure continuous compliance with applicable GMP and international regulatory requirements.
- Handle and coordinate USFDA, EU GMP, MHRA, WHO-GMP, PIC/S and other regulatory inspections.
- Lead customer audits and ensure timely closure of audit observations.
- Review and strengthen systems covering Deviation, CAPA, Change Control,
Investigation, Risk Management and APR/PQR.
- Provide QA oversight for validation and qualification activities.
- Identify quality and compliance risks and drive appropriate corrective actions.
- Work closely with Production, QC, Regulatory Affairs, Engineering, Supply Chain and other functions.
- Promote a strong GMP and quality culture across the manufacturing site.
- Lead, coach and develop the QA team and build a strong second line of leadership.
- Drive improvements in quality systems, compliance standards and operational effectiveness.
Candidate Profile
- 1725 years of experience in Pharmaceutical Quality Assurance.
- Strong experience in OSD / Oral Solid Dosage Formulations is mandatory.
- Experience in a regulated pharmaceutical manufacturing environment.
- Proven exposure to international regulatory inspections and customer audits.
- Strong knowledge of GMP, QMS, CAPA, Deviations, Change Contro
📌 General Manager Quality Assurance Formulations (Hyderabad)
🏢 Selective Global Search
📍 Hyderabad
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