Quality Assurance Manager (OSD Facility)

Immacule Lifesciences; Solan; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Immacule Lifesciences in India seeks a senior leader to own Quality Assurance and QMS stewardship across the organization. You will oversee GMP-compliant QA activities, approve SOPs, manage deviations, CAPA, and regulatory compliance, and ensure timely batch releases across materials and finished products.

The role requires 12–16 years in pharmaceutical QA with hands-on QMS, audits, investigations, and risk management.

Qualifications

• 12–16 years of experience in Pharmaceutical Quality Assurance, preferably in regulated environments.
• Strong hands-on experience in QMS, audits, investigations, CAPA, deviations, OOS/OOT, validation and regulatory compliance.

Responsibilities

• Lead QA & QMS activities to ensure cGMP compliance and regulatory readiness.
• Review and approve SOPs, BMR/BPR, specs, validation docs, and quality records.
• Manage OOS/OOT, deviations, CAPA, changes, complaints, recalls and investigations.
• Ensure effective IPQA, data integrity, quality risk mgmt, self-inspections and audit readiness.
• Oversee batch release decisions and material approvals; ensure timely validation and calibration.

Skills

QMS

Audits

CAPA

Validation

Deviations

Regulatory

Data integrity

Education

Bachelor's degree in Pharmacy / Pharmaceutical Sciences

Job description

• Lead overall Quality Assurance and Quality Management System (QMS) activities in compliance with cGMP and regulatory requirements.
• Review and approve SOPs, BMR/BPR, specifications, validation/qualification documents, SMF, VMP and other quality documents.
• Manage OOS/OOT, deviations, CAPA, change controls, complaints, recalls and investigations.
• Ensure effective implementation of IPQA, data integrity, quality risk management, self‑inspections and audit compliance.
• Approve/review batch release, raw materials, packaging materials, intermediates and finished products.
• Ensure timely execution of process/cleaning/equipment validation, calibration, preventive maintenance and stability studies.
• Lead regulatory, customer and GMP audits, including inspection readiness and timely closure of observations.
• Review and approve Quality/Technical Agreements and monitor contract manufacturers, suppliers and external laboratories.
• Ensure compliance with pharmacopoeial, regulatory and statutory changes and their effective implementation.
• Oversee new product introduction and technology transfer from the Quality perspective.
• Conduct Quality Review Meetings and ensure timely closure of QMS activities.
• Drive continuous improvement and develop a strong quality culture across the organization.
• Lead and develop the QA team through manpower planning, work allocation, KRA setting and performance management.
• Ensure adequate manpower, budget and resources for the QA function.
• Coordinate cross-functionally with Manufacturing, QC, Engineering, Warehouse and other departments to maintain continuous GMP compliance and audit readiness.

Desired Profile

• 12-16 years of relevant experience in Pharmaceutical Quality Assurance, preferably in a regulated/USFDA environment.
• Strong hands‑on experience in QMS, audits, investigations, CAPA, deviations, OOS/OOT, validation and regulatory compliance.