Description:
- Candidate must have 2 to 4 years of industrial experience in a reputed Pharma /Life science domain
- Candidate must have an equivalent combination of working experience in QA activities along with IT and CSV domains.
- In-depth knowledge of various following regulatory guidance
- 21 CFR Part 11, Electronic Records; Electronic Signatures
- Annex 11: Computerized Systems, European Commission, Health and
Consumers Directorate-General
- GAMP 5: Good Automated Manufacturing Practices
- WHO, MHRA & USFDA guidance
- ICH Q7, Q8, Q9 & Q10
- Data integrity guidance
- Work experience in both the IT sector and the pharma sector will be desirable.
- Hands-on experience and knowledge of various software (including manufacturing, laboratory, enterprise, SAP, warehouse, etc.)
- Experience in validation on automation/digitization projects
- Should be good in communication skills (verbal and written), good documentation and technical writing skills, Good logical thinking, problem-solving, and decision-making skills
- Candidate should have good exposure to handling CSV for the enterprise application like SAP, Track wise
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