Role & responsibilities

Job Description Deputy Manager – Corporate Quality Assurance (CQA) – Sterile Injectables

Position: Deputy Manager – Corporate Quality Assurance (CQA) – Sterile Injectables

Key Responsibilities

- Ensure compliance with cGMP, GDP, Data Integrity, and global regulatory requirements across sterile injectable manufacturing sites.
- Review and approve quality documents including SOPs, Master Batch Records (MBRs), specifications, protocols, reports, and validation documents.
- Oversee Quality Management System (QMS) activities such as Deviations, CAPA, Change Control, OOS/OOT, Risk Assessments, and Product Quality Reviews (PQR/APQR).
- Support technology transfer, process validation, cleaning validation, equipment qualification, and aseptic process validation.
- Conduct internal audits, vendor audits, and self-inspections to ensure regulatory compliance.
- Coordinate and support regulatory inspections by USFDA, MHRA, EU-GMP, WHO-GMP, TGA, and other health authorities.
- Monitor compliance trends, implement quality improvements, and drive CAPA effectiveness.
- Review batch release documentation and ensure compliance with corporate quality standards.
- Provide quality oversight for manufacturing,



engineering, warehouse, microbiology, and quality control functions.
- Train and mentor QA teams on regulatory expectations, quality systems, and data integrity requirements.

Required Skills

- Corporate Quality Assurance (CQA)
- Sterile Injectables
- Quality Management System (QMS)
- cGMP, GDP & Data Integrity
- Deviation, CAPA & Change Control
- OOS/OOT Investigation
- Risk Assessment (ICH Q9)
- Product Quality Review (PQR/APQR)
- Process Validation
- Cleaning Validation
- Equipment Qualification
- Aseptic Process Validation (Media Fill)
- Regulatory Audits (USFDA, MHRA, EU-GMP, WHO-GMP)
- Internal & Vendor Audits
- Batch Record Review & Batch Release
- Documentation Management
- Team Leadership & Cross-functional Coordination

Qualification

- B.Pharm / M.Pharm / M.Sc (Life Sciences, Pharmacy, Microbiology, Biotechnology, or related discipline)

Experience

- 10–15 Years in Corporate Quality Assurance or Quality Assurance for Sterile Injectables, with hands-on experience in regulatory compliance, QMS, validation, and global regulatory inspections.

Preferred candidate profile

📌 CQA Deputy Manager - Injectables (Hyderabad)
🏢 Aspiro Pharma
📍 Hyderabad