Role & responsibilities

Deputy Manager, QA (QMS)

Qualification: M.Pharm / B.Pharm / M.Sc. (Chemistry, Microbiology). Experience: 10-14 years in pharma QA, with at least 5 years in sterile injectables.

Responsibilities

- Manage day-to-day operation of the deviation, CAPA, change control, OOS/OOT and market complaint systems, ensuring timely closure
- Review and approve investigations for aseptic process, media fill, sterility failure, environmental monitoring excursions and particulate-related deviations
- Review and approve change controls with regulatory, validation and product quality impact assessment
- Lead the self-inspection programme and track observations to closure
- Review and approve SOPs, protocols, and qualification/validation documents for equipment, utilities, cleanroom and cleaning validation
- Prepare and review APQR, quality metrics and QMS trend reports
- Ensure data integrity compliance (ALCOA+), including audit trail review practices
- Support regulatory and customer audits: prepare the site, handle back-room/front-room activities, draft and track responses
- Manage vendor qualification and audit coordination for critical materials (e.g., stoppers, vials, APIs)
- Conduct GMP and QMS training, and mentor Executives and Senior Executives
- Report QMS KPIs to site management

Manager, QA (QMS)

Qualification: M.Pharm / M.Sc. (preferably with a quality-related certification). Experience: 14-18 years in pharma QA, with at least 8 years in sterile injectables and prior team leadership.

Additional and expanded responsibilities

- Own the site QMS framework and ensure alignment with corporate quality policies and global regulations (21 CFR 210/211, EU GMP Annex 1, PIC/S, ICH Q9/Q10)




- Drive the Annex 1 CCS (Contamination Control Strategy) implementation, gap assessments and quality risk management programme
- Chair or co-chair the Quality Review Board, change control board and deviation review forums
- Provide final QA approval for critical and major deviations, recalls, field alerts and batch-impacting investigations
- Lead preparation and conduct of regulatory inspections (USFDA, EMA, MHRA, WHO, TGA, ANVISA, etc.) and own observation responses and commitments
- Lead the management review process, defining quality metrics, trends and improvement priorities
- Ensure effective CAPA, with focus on systemic root cause and recurrence prevention
- Oversee data integrity governance, computerised system validation oversight and Part 11 compliance
- Approve quality agreements and manage customer and contract partner interactions
- Build, develop and manage the QMS team, including goal setting, appraisals and succession planning
- Manage QA budget, resourcing and cross-functional alignment with Production, QC, Engineering, Regulatory Affairs and Supply Chain
- Drive continuous improvement, digitisation of QMS (e.g., eQMS) and a quality culture on the shop floor

Key skills

Deep knowledge of sterile GMP and regulatory guidelines, investigation and root cause analysis tools (5-Why, Fishbone, FMEA), risk management, audit and inspection handling, eQMS tools (TrackWise, Veeva, etc.), solid communication, decision-making under pressure, and people leadership.

Typical KPIs

- On-time closure of deviations, CAPA and change controls
- Repeat deviation rate
- Audit and inspection outcomes (number and criticality of observations)
- Batch release and review turnaround
- Training compliance
- Complaint trends and closure time

Preferred candidate profile

📌 Deputy Manager / Manager - QMS /IPQA (Hyderabad)
🏢 Aspiro Pharma
📍 Hyderabad