Positions open1. Head of Production QMS — Manager / Senior Manager Owns the function end to end. Builds and leads the team, sets investigation and closure standards, and represents production on quality systems during regulatory inspections.

2. Investigation Lead — Assistant Manager / Manager Leads investigations for deviations, incidents and aseptic excursions originating in manufacturing. Drives root cause analysis, impact assessment, CAPA and effectiveness verification.

3. Training, Change Management, Trending & Batch Record Review — Executive / Senior Executive / Assistant Manager (multiple positions) Runs the recurring quality systems: personnel training and aseptic qualification, production change controls, trend analysis, and production-side review of BMRs and BPRs.

What the function is responsible forDepending on your level and position, you will own or contribute to:

- Deviations and investigations — end-to-end lifecycle for manufacturing events, structured root cause analysis, product impact assessment, and defensible investigation reports.
- CAPA — defining, driving and verifying corrective and preventive actions, including effectiveness checks and escalation where actions are not landing.
- Change control — impact assessment, cross-functional approvals, implementation and closure of production-initiated changes.
- Training and qualification — induction, GMP refreshers, SOP and on-the-job training, gowning and aseptic technique qualification, training matrices and effectiveness evaluation.
- Trending — analysis across deviations, incidents, CAPAs, change controls, line clearance events and production-relevant environmental monitoring data, feeding management review and APQR.
- Batch record review — production-side review of BMRs and BPRs for completeness, GDP compliance,



data integrity and deviation linkage, driving right-first-time documentation.
- Inspection readiness — front-room and back-room support during regulatory and customer audits, and ownership of production commitments in observation responses.
- Quality risk management — risk assessments, QRM and FMEA for current products, line changes and process modifications.

What we are looking forEssential across all positions

- B.Pharm / M.Pharm / B.Tech / M.Tech/ M.Sc. in a relevant discipline.
- Hands-on experience in sterile injectables — aseptic processing, media fills, line clearance, environmental monitoring, gowning qualification.
- Experience in a regulated GMP environment with exposure to global regulatory inspections.
- Strong technical writing and documentation discipline in English.
- Working knowledge of data integrity and ALCOA+ principles in daily practice.
- Willingness to be on the floor. We value people who gown up and go see the event rather than manage it from a desk.

Experience by level

Executive / Senior Executive 2–6 years

Assistant Manager / Manager 6–12 years

Senior Manager 12+ years, including team leadership

Valued additionally

- Formal training in root cause analysis methodologies (5 Why, Ishikawa, fault tree, human error analysis).
- Experience with any eQMS platform
- Experience authoring or driving closure of responses to regulatory observations.
- Training delivery experience for shop-floor teams.

Why join us
- An FDA-approved sterile injectables site with multiple aseptic lines and an active expansion agenda (multi sites)
- A Production QMS function being built now — real scope to shape systems rather than inherit them.
- Direct exposure to global regulatory inspections and international customers.
- Leadership that takes quality systems seriously and backs the function.

📌 Executive/Sr. Executive/Asst. Manager/Manager/Sr. Manager - Production QMS (Hosur)
🏢 Maiva Pharma Private Limited (FDA Approved Sterile Injectables)
📍 Hosur