Senior Manager - QA (Sterile)

USV; Vapi; On-site; INR 3,000,000 - 4,000,000; Full time

Job summary

USV (Pharma) is seeking a Senior Manager - QA (Sterile) for its USFDA Formulation Manufacturing Plant near Daman, close to Vapi. The role requires deep expertise in IPQA, qualification and validation, and QMS with aseptic techniques to ensure product quality and regulatory readiness.

You will lead internal and external audits, drive CAPA and deviation management, and mentor QA and production teams to sustain ALCOA+ data integrity. Strong comms and cross-functional collaboration are essential.

Qualifications

• Thorough knowledge of IPQA, qualification and validation, and QMS aseptic techniques.
• Experience facing regulatory audits (USFDA, MHRA, EU GMP, TGA) and ability to explain auditors during inspections.
• 15+ years of experience in sterile injectables manufacturing (Liquid Vials, Ophthalmic, and Pre-filled syringes).

Responsibilities

• Oversee and manage QMS processes including Deviation Management, CAPA, Change Control, Risk Management, and Product Quality Reviews (PQRs).
• Lead Quality investigations and root cause analysis for process deviations and quality events.
• Ensure timely closure of audit observations and effective CAPA implementation.
• Monitor and review QMS KPIs and drive continuous improvement initiatives.
• Coordinate and lead internal and external audits (regulatory and customer).
• Ensure sterile area compliance through regular review of processes, documentation, and trending of quality data.
• Lead training initiatives related to QMS and GMP for the QA and production teams.
• Collaborate with cross-functional teams (Production, QC, Regulatory Affairs, etc.) to ensure QMS effectiveness and product quality.
• Review and approve master documents related to QMS (SOPs, protocols, reports).
• Support data integrity initiatives and ensure compliance with ALCOA+ principles.
• Maintain readiness for regulatory inspections and support inspection management activities.

Skills

IPQA

Qualification and Validation

QMS Aseptic techniques

Regulatory Audit readiness

Job description

USV (Pharma) is Hiring Senior Manager - QA (Sterile) for USFDA Formulation Manufacturing Plant based at Daman near Vapi.

We are looking for dynamic professionals having more than 15 years of experience in hard core injectables (Liquid Vials, Ophthalmic and Pre-filled syringes).

The incumbent must be having the thorough knowledge of IPQA, Qualification and Validation, QMS Aseptic techniques and practices.

Should have faced the Regulatory Audit (USFDA, MHRA, EU GMP, TGA) and should be able to explain the auditors during inspections.

Excellent verbal and written communication are expected.

• Oversee and manage QMS processes including Deviation Management, CAPA, Change Control, Risk Management, and Product Quality Reviews (PQRs).
• Lead Quality investigations and root cause analysis for process deviations and quality events.
• Ensure timely closure of audit observations and effective CAPA implementation.
• Monitor and review QMS KPIs and drive continuous improvement initiatives.
• Coordinate and lead internal and external audits (regulatory and customer).
• Ensure sterile area compliance through regular review of processes, documentation, and trending of quality data.
• Lead training initiatives related to QMS and GMP for the QA and production teams.
• Collaborate with cross-functional teams (Production, QC, Regulatory Affairs, etc.) to ensure QMS effectiveness and product quality.
• Review and approve master documents related to QMS (SOPs, protocols, reports).
• Support data integrity initiatives and ensure compliance with ALCOA+ principles.
• Maintain readiness for regulatory inspections and support inspection management activities.