Quality Assurance Manager (Injectable)

Milan Laboratories; Dahej; On-site; INR 1,800,000 - 2,600,000; Full time

Job summary

Milan Laboratories seeks an experienced Manager QA to lead QA activities for our Injectable Small Volume Parenteral (SVP) manufacturing facility. The role focuses on sterile process quality, regulatory compliance, and strong quality systems across operations.

Key responsibilities include directing QA for injectable operations, ensuring cGMP adherence, overseeing IPQA, line clearance, and review of BMR/BPR and GMP documents, while promoting data integrity and a robust quality culture.

Qualifications

• Experience in sterile pharmaceutical manufacturing and QA systems (GMP/regulatory).
• Handle deviations, CAPA, change controls and quality investigations.
• Oversee IPQA activities across manufacturing and packing operations.
• Review and approve BMR/BPR and other GMP-related documents.

Responsibilities

• Lead QA activities for Injectable/SVP manufacturing operations.
• Ensure compliance with cGMP, regulatory requirements, SOPs and company quality standards.
• Oversee IPQA activities across manufacturing and packing operations.
• Ensure effective line clearance, in-process checks and batch documentation review.
• Review and ensure compliance of water systems, HVAC and other critical utilities.

Skills

QA Management

GMP/Regulatory Compliance

Sterile Manufacturing

IPQA

Aseptic Processing

CAPA & Deviation Handling

BMR/BPR Review

Environmental Monitoring

Water Systems & HVAC QA

Quality Culture & Data Integrity

Job description

We are looking for an experienced Manager QA to lead Quality Assurance activities for our Injectable Small Volume Parenteral (SVP) manufacturing facility. The ideal candidate should have strong experience in sterile pharmaceutical manufacturing, quality systems and regulatory compliance. Small Volume Parenteral (Injectable) manufacturing facility.

Roles and Responsibilities

• Lead and manage overall QA activities for Injectable / SVP manufacturing operations.
• Ensure compliance with cGMP, regulatory requirements, SOPs and company quality standards.
• Oversee IPQA activities across manufacturing and packing operations.
• Ensure effective line clearance, in-process checks and batch documentation review.
• Review and approve BMR/BPR and other GMP-related documents.
• Manage and review deviations, OOS/OOT, CAPA, change controls and quality investigations.
• Ensure implementation and monitoring of Environmental Monitoring requirements for sterile areas.
• Oversee QA activities related to aseptic processing, filling, sterilization and sterile manufacturing operations.
• Ensure compliance with cleanroom practices, contamination control and aseptic practices.
• Support media fill / aseptic process simulation activities.
• Review and ensure compliance of water systems, HVAC and other critical utility-related QA requirements.
• Coordinate with Production, QC, Engineering, Microbiology and other departments for quality-related activities.
• Prepare the facility and team for regulatory inspections, customer audits and internal audits.
• Ensure timely implementation and closure of CAPA and audit observations.
• Promote a strong Quality Culture and Data Integrity across the organization.
• Lead, train and develop the QA team to ensure effective performance.
• Strong experience in Injectable / Sterile manufacturing, preferably SVP.
• Hands-on experience in QA operations and pharmaceutical Quality Management Systems.