Sr Mgr - QA (Sterile)

PeopleStrong; Daman; On-site; INR 2,800,000 - 4,000,000; Full time

Job summary

USV (Pharma) is seeking a Senior Manager - QA (Sterile) for a USFDA Formulation Manufacturing Plant based at Daman near Vapi. The role demands 15+ years in sterile injectables and thorough QMS, IPQA, and validation expertise to lead regulatory readiness and product quality.

The incumbent will spearhead deviations, CAPA, audits, and data integrity initiatives while collaborating with Production, QC, and Regulatory Affairs to ensure compliance and continuous improvement in a highly regulated

Qualifications

• Experience in IPQA processes for sterile injectables including QC, manufacturing and QA interfaces.
• Strong knowledge of Validation life-cycle (IQ/OQ/PQ) and qualification activities.
• Proficiency in aseptic techniques and sterile manufacturing environments.
• Deep understanding of QMS and documentation control in GMP settings.
• Experience with regulatory audits (USFDA/MHRA/EU GMP/TGA) and audit readiness.

Responsibilities

• Oversee and manage QMS processes including Deviation Mgmt, CAPA, Change Control, Risk Mgmt, and PQRs.
• Lead Quality investigations and root cause analyses 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

Validation

Aseptic Techniques

QMS

Regulatory Audits

CAPA

Deviation Mgmt

Change Control

Root Cause Analysis

Data Integrity

GMP Training

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.