Quality Assurance Manager (Injectable)

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.
  

Apply Now: https://docs.google.com/forms/d/e/1FAIpQLSejy8w5cVlkIE8wz1CRODL6Xp6EmNFHgyDX9xXzQ_5wc_9SZA/viewform?usp=header