CSV QA Engineer -
Description:
Candidate must have 1 to 3 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.
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
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
A team leader with good 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 Project Location 1 MAH | MUMBAI Relevant Experience 5 Mandatory skills Candidate must have an equivalent combination of working experience in CQA activities along with IT and CSV domains Desired skills #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 Domain (Industry) Pharma(CQA) Total Experience (Ex. 5-7 Years) 3-5yrs WFO / WFH / Hybrid WFO Please enter shift timings 9-6 Shift Timings General
Location- Airoli, Navi Mumbai
Yrs of Exp-3+Yrs
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