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