LS-ADM-CQA

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 good 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