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 (India)
🏢 Aspiro Pharma
📍 India