Assistant General Manager Quality Assurance (Sterile)

Acme Formulation; Solan; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Acme Formulation in Solan, Himachal Pradesh, seeks a senior Quality Assurance lead to oversee sterile manufacturing QA, ensuring cGMP compliance, QMS integrity, and regulatory alignment. You will review validation data, approve batch release, and drive CAPA-driven improvements across the plant.

The role requires 16+ years in pharmaceutical QA with sterile manufacturing experience, and a strong track record in audits and team leadership. M.Pharm/B.Pharm/M.Sc. or equivalent is preferred.

Qualifications

• 16+ years in Pharmaceutical Quality Assurance
• Significant experience in Sterile/Injectable manufacturing
• Experience leading QA functions and audits

Responsibilities

• Lead and maintain the Quality Management System (QMS) across the plant.
• Ensure cGMP compliance, regulatory guidelines, SOPs, and data integrity.
• Review and approve quality documents, validation protocols/reports, BMR/BPR, PQR/APR, stability data, and master documents.
• Approve batch disposition and release finished products.
• Lead investigations related to deviations, OOS/OOT, complaints, recalls, and ensure CAPA implementation.
• Review and approve Technology Transfer documents and oversee new product introductions.
• Monitor validation, qualification, calibration, and preventive maintenance compliance.
• Lead internal, external, vendor, customer, and regulatory audits; ensure closure of observations.
• Review trend analysis and communicate critical quality issues to Management and Regulatory Authorities.
• Approve vendor qualifications, technical agreements, and external testing laboratories.
• Ensure GMP compliance for new facilities, utilities, equipment, and projects.
• Lead, develop, and optimize the QA team; ensure effective resource utilization.
• Ensure compliance with EHS, hygiene, and environmental standards.

Skills

Sterile manufacturing

QMS & regulatory compliance

Validation & qualification

Batch release

Investigation & CAPA

Audit management

Data integrity

Leadership & team management

Education

M.Pharm / B.Pharm / M.Sc. or equivalent

Job description

Job Purpose

Lead the Quality Assurance function for Sterile Manufacturing by ensuring compliance with cGMP, regulatory requirements, Quality Management Systems (QMS), and quality standards while driving continuous improvement and audit readiness.

Key Responsibilities

• Lead and maintain the Quality Management System (QMS) across the plant.
• Ensure compliance with cGMP, regulatory guidelines, SOPs, and data integrity requirements.
• Review and approve quality documents, validation protocols/reports, BMR/BPR, PQR/APR, stability data, and master documents.
• Approve batch disposition and release finished products.
• Lead investigations related to deviations, OOS/OOT, complaints, recalls, and ensure effective CAPA implementation.
• Review and approve Technology Transfer documents and oversee new product introductions.
• Monitor validation, qualification, calibration, and preventive maintenance compliance.
• Lead internal, external, vendor, customer, and regulatory audits and ensure timely closure of observations.
• Review trend analysis and communicate critical quality issues to Management and Regulatory Authorities.
• Approve vendor qualifications, technical agreements, and external testing laboratories.
• Ensure GMP compliance for new facilities, utilities, equipment, and projects.
• Lead, develop, and optimize the QA team while ensuring effective resource utilization.
• Ensure compliance with EHS, hygiene, and environmental standards.

Preferred candidate profile

Experience

16+ Years in Pharmaceutical Quality Assurance with significant experience in Sterile/Injectable manufacturing.

Qualification

M.Pharm / B.Pharm / M.Sc. or equivalent.

Key Competencies

• Sterile Manufacturing & Aseptic Processing
• QMS & Regulatory Compliance
• Validation & Qualification
• Batch Release
• Investigation & CAPA
• Audit Management
• Data Integrity
• Leadership & Team Management