ECMS REQ ID
544196
PU
LS-ADM
Number of Openings
1
Country
India
Detailed JD (Roles and Responsibilities)
- 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
Ø 21 CFR Part 11, Electronic Records; Electronic Signatures
Ø Annex 11: Computerized Systems, European Commission, Health and
Consumers Directorate-General
Ø GAMP 5: Good Automated Manufacturing Practices
Ø WHO, MHRA & USFDA guidance
Ø ICH Q7, Q8, Q9 & Q10
Ø 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 positive exposure to handling CSV for the enterprise application like SAP, Track wise
Total Experience
3-5 yrs
Relevant Experience
1 to 3yrs
Mandatory skills
CQA
Desired skills expertise in validating GxP-regulated computerized systems in alignment with global regulatory guidelines- GxP, FDA, USFDA , 21 CFR Part 11, EU Annex 11, WHO, GAMP 5 , MHRA and ALCOA+++ principles of data integrity.
Domain (Industry)
Life Science(Pharma)
Work Location
Mumbai
Background Check (Before onboarding / After onboarding)
Before Onboarding
Mode of Interview- Telephonic/Face to Face/Video Interview
Video
WFO / WFH / Hybrid
WFO
Shift Details (Time)
9AM- 5PM IST
Client Name
LUPIN
Client BTP / SHTP (onsite)
Mumbai
Vendor Rate per day in currency of Work Location
4000
INR/day
📌 Ls-Adm-Cqa (India)
🏢 Clifyx
📍 India