Role & responsibilities

Key Responsibilities

- Lead Corporate Quality Assurance activities across sterile injectable manufacturing facilities.
- Ensure compliance with USFDA, MHRA, EU GMP, WHO-GMP, PIC/S, and applicable regulatory requirements.
- Develop, implement, and monitor the Quality Management System (QMS).
- Drive quality compliance through management of Deviations, CAPA, Change Control, OOS, OOT, Risk Assessments, Investigations, and Data Integrity.
- Lead internal audits, corporate quality audits, vendor audits, and self-inspection programs.
- Prepare manufacturing sites for regulatory inspections and customer audits; support audit responses and CAPA effectiveness.
- Review and approve quality documents, SOPs, validation protocols/reports, annual product quality reviews (APQR/PQR), and quality metrics.
- Provide oversight for process validation, cleaning validation, equipment qualification, and technology transfer from a quality perspective.




- Ensure implementation of quality risk management (ICH Q9), cGMP compliance, and continuous improvement initiatives.
- Mentor and lead QA teams while collaborating with Manufacturing, QC, Engineering, Validation, Regulatory Affairs, and Supply Chain.
- Monitor quality KPIs and drive compliance culture across all manufacturing locations.

Required Qualifications

- M.Pharm / B.Pharm / M.Sc (Life Sciences/Chemistry/Microbiology or related discipline).
- 1522 years of experience in the pharmaceutical industry, with significant experience in Corporate QA and Sterile Injectables.
- Proven exposure to USFDA-approved sterile injectable facilities.
- Solid experience handling USFDA, MHRA, EU GMP, WHO-GMP inspections and regulatory compliance.

Preferred candidate profile

📌 AGM & General Manager - Corporate Quality Assurance - Injectables (Telangana)
🏢 Aspiro Pharma
📍 Telangana