Number of Openings

5

ECMS ID in sourcing stage

520642

Assignment Duration

6 months – 1 Year

Total Yrs. of Experience

6+ Years

Relevant Yrs. of experience

6+ Years

Detailed JD (Roles and Responsibilities)

- 6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.
- Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ's, TRM.
- Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation.
- Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.
- Stakeholder management and good executor with required communication.
- Candidate must have fair conceptual understanding on below key areas
- IT QMS
- Validation/Qualification
- Risk management.
- Handling of defects/Deviations
- Investigations
- CAPA Handling
- Test Management & Compliance

- Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.
- Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc.

Mandatory skills
- 6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.
- Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ's, TRM.
- Assure compliance with GxP (GMP, GCP, GLP)



& privacy requirements. Develops and maintains IT GxP compliance documentation.
- Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.
- Stakeholder management and valuable executor with required communication.
- Candidate must have fair conceptual understanding on below key areas
- IT QMS
- Validation/Qualification
- Risk management.
- Handling of defects/Deviations
- Investigations
- CAPA Handling
- Test Management & Compliance

- Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.
- Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc.

Desired/ Secondary skills
- Hands-on experience on testing tools like Client ALM, Kneat and SNOW

- Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage
- OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)
- Client/DCS Qualification
- ISA95 High level of understanding
- OT Security will be a plus.
- Standalone Systems Qualifications
- Client/DCS Integrated with Manufacturing Equipment qualification.

Domain

Lifesciences

Max Vendor Rate in Per Day (Currency in relevance to work location)

INR 8700/day

Delivery Anchor for tracking the sourcing statistics, technical evaluation, interviews, and feedback etc.

Ramya Velraj Ramkumar Subramanian Prashant Mathpati

Work Location given in ECMS ID

Pune (but requirements are in throughout India)

WFO/WFH/Hybrid WFO

Hybrid

BG Check (Before OR After onboarding)

Before

Is there any working in shifts from standard Daylight (to avoid confusions post onboarding) YES/ NO

No

📌 GxP (Bengaluru)
🏢 Clifyx
📍 Bengaluru