Hetero Drugs Recruiting For Asst Manager/Dy Manager-IT-QA .Hetero is one of India’s leading generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs. Hetero’s business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics.
Eligibility and other details :
- Post Name: Asst Manager/Dy Manager-IT-QA
- Qualification: Any Graduate with 08-10 Years of Experience
- Location: Hyderabad
- Salary: Not Disclosed
- No Vacancies: 01
- Selection Process : Based on Resume Received,will shortlist.
Job description:
- 1. Harmonization and Implementation of IT Quality Systems and practices at API & FDF manufacturing sites in compliance with cGMP requirements of different regulatory agencies. 2. Expertise on ICH guidelines 3. Electronic signatures and requirements of FDA 21 CFR Part 11 & EU GMP Annex 11 4. Risk-based approach (GAMP 5) for Validation of Computerized Systems 5. Software Classification, IT Risk Assessment and Mitigation Strategy 6. Expertise in integrating technology with manufacturing process transformation programs to visualize business functions. 7. Expertise in Gap Assessment and Remediation procedures for Stand-alone applications to ensure validation policy is in line with Life Cycle Approach 8.Demonstrate Business Process initiatives aligned with Information Technology along with validation deliverables
