Senior Manager/ Assistant General Manager -IT Compliance Department

Emcure; Pune District; On-site; INR 3,500,000 - 7,000,000; Full time

Job summary

Emcure in Pune Hinjewadi seeks a Senior Manager/Assistant General Manager - IT Compliance to lead IT compliance initiatives within the pharmaceutical landscape. The role focuses on audits, validation, SOP reviews, and regulatory alignment for GxP and 21 CFR Part 11.

The ideal candidate will hold a Masters degree and bring strong pharmaceutical industry experience to strengthen compliance frameworks in a fast-paced environment.

Qualifications

• Masters degree in pharmacy, Life Sciences, Engineering, CS, or IT.
• Currently working in the pharmaceutical industry.

Responsibilities

• Oversee IT compliance audits, application assessments, validation documentation, and SOP reviews.
• Ensure regulatory compliance for GxP and 21 CFR Part 11 in IT systems.
• Lead the IT compliance function within the department.

Skills

CSV

IT Compliance

GxP

21 CFR Part 11

Education

Masters degree in pharmacy, Life Sciences, Engineering, CS, or IT

Job description

Role: Senior Manager/Assistant General Manager -IT Compliance Department

Job Location: Pune Hinjewadi

Required Experience:

• Strong experience in CSV, IT Compliance/Quality, GxP, and 21 CFR Part 11.
• Pharmaceutical/Life Sciences industry experience preferred.
• Strong experience in audits, application assessment, validation documentation, SOP review, and regulatory compliance.

Qualification : Masters degree in pharmacy, Life Sciences, Engineering, Computer Science, Information Technology.

Only candidates currently working in the pharmaceutical industry may apply