About Yenepoya Technology Incubator

Yenepoya Technology Incubator, an initiative of Yenepoya (Deemed to be University), supports healthcare and life science entrepreneurship through advanced technical infrastructure. YTI operates an ISO 13485 certified facility and Class 1,000 / Class 10,000 cleanroom environments supporting pharmaceutical testing, research, and pilot manufacturing under CDSCO and State Licensing Authority permissions.

Position Summary

We are seeking a qualified pharmaceutical Quality Assurance professional to lead quality operations across our cleanroom and analytical infrastructure. The candidate will be responsible for maintaining the Quality Management System, managing compliance with Schedule M and international regulatory guidelines, leading audit readiness programs, and serving as the primary technical interface during regulatory inspections.

Key Responsibilities

- Manage and maintain the site Quality Management System in full alignment with Schedule M and ISO standards.
- Author, review, and approve Standard Operating Procedures, Master Batch Records, validation master plans, and qualification protocols.
- Oversee deviation investigations, root cause analysis, CAPA implementation, and change control procedures.
- Direct facility qualification, HVAC environmental monitoring, equipment validation, and analytical data integrity programs.




- Lead internal quality audits and represent the organization as the technical QA lead during joint CDSCO and State Drug Control inspections.
- Provide quality oversight and technical guidance to internal teams and incubatees operating within the cleanroom facilities.

Qualifications and Requirements

- Education: B.Pharm or M.Pharm degree from a Pharmacy Council of India (PCI) recognized institution.
- Experience: 4 to 8 years of core Quality Assurance experience in a regulated pharmaceutical manufacturing facility.
- Technical Exposure: Direct experience with Schedule M compliance, cleanroom validation, equipment qualification, and data integrity systems.
- Audit Track Record: Demonstrated experience in leading or key participation in regulatory audits conducted by State Licensing Authorities or CDSCO.
- Regulatory Knowledge: Solid command over the Drugs and Cosmetics Act & Rules, ISO 13485, and current GMP practices.

Job Type: Full-time

Perks:

- Commuter assistance
- Health insurance

Ability to commute/relocate:

- Mangalore, Karnataka: Reliably commute or planning to relocate before starting work (Preferred)

Application Question(s):

- Have you worked in an industry setup complying with GMP/ISO?

Experience:

- QA: 4 years (Preferred)

Work Location: In person

📌 Pharma Quality Assurance Executive / Manager (India)
🏢 Yenepoya Technology Incubator
📍 India