Quality Assurance Lead

Maya Biotech; Solan; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Maya Biotech in Himachal Pradesh seeks a seasoned QA Lead to oversee all Quality Assurance operations at the Baddi plant, ensuring compliance with WHO-GMP, cGMP and data integrity for sterile injectable products.

The role requires strong leadership, deep knowledge of QMS, audits, and regulatory submissions, with 12+ years of pharma QA experience and a track record of guiding cross-functional teams to maintain quality systems and regulatory readiness.

Qualifications

• 12+ years of experience in QA for pharma
• Strong exposure to injectable manufacturing
• Experience with WHO-GMP, cGMP compliance

Responsibilities

• Manage overall QA functions for sterile injectable plant.
• Ensure compliance with cGMP, WHO-GMP, and regulatory requirements.
• Review and approve BMR/BPR, SOPs, specifications, protocols, and validation documents.
• Handle deviations, CAPA, change controls, OOS, and investigations.
• Monitor data integrity and documentation practices.
• Ensure qualification and validation activities are completed.
• Oversee line clearance and in-process QA activities.
• Support regulatory submissions and audit readiness.
• Train QA team on GMP and compliance practices.
• Coordinate with Production, QC, Engineering, and Warehouse departments.

Skills

Sterile injectable regulations

Leadership

QMS & Audits

Documentation

Education

B.Pharm

M.Pharm

MSc

Job description

QA Lead (Quality Assurance Lead)

Location

Baddi Plant, Himachal Pradesh

Experience

12+ years

Qualification

• B.Pharm / M.Pharm / MSc
• Strong exposure to injectable manufacturing

Job Summary

The QA Lead will be responsible for overall Quality Assurance operations at the manufacturing facility, ensuring compliance with WHO-GMP, cGMP, regulatory guidelines, data integrity, and quality systems for injectable products.

Key Responsibilities

• Manage overall QA functions for sterile injectable plant.
• Ensure compliance with cGMP, WHO-GMP, and regulatory requirements.
• Review and approve BMR/BPR, SOPs, specifications, protocols, and validation documents.
• Handle deviations, CAPA, change controls, OOS, and investigations.
• Monitor data integrity and documentation practices.
• Ensure qualification and validation activities are completed.
• Oversee line clearance and in-process QA activities.
• Support regulatory submissions and audit readiness.
• Train QA team on GMP and compliance practices.
• Coordinate with Production, QC, Engineering, and Warehouse departments.

Required Skills

• Strong knowledge of sterile injectable regulations.
• Leadership and team handling skills.
• Good understanding of QMS and audit management.
• Strong communication and documentation skills.