Responsibilities :
- Candidate will provide an application validation expertise practically on different scenarios as applicable case to case , standalone / enterprise etc.
- Candidate will be accountable for authoring Validation Plan, and Validation Summary Reports and have fair understanding on other SDLC documents.
- 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 , CFR Part , EU annex , and Guidelines , GAMP guide.
- OT System Qualification. (Radio ligand Therapy or critical dosage forms will be a plus)
- Client / DCS Qualification.
- ISA High level of understanding.
- OT Security will be a plus.
- Standalone Systems Qualifications.
- Client / DCS Integrated with Manufacturing Equipment qualification.
Requirements :
- to years 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.
- Well versed with Manufacturing, Quality and engineering system and their validations.
- Stakeholder management and good executor with required communication.
- Knowledge of Pharmaceutical / Life Sciences as domain.
- Experience to MES, QMS (Track wise), Lab solutions , LIMS, Empower CDS, Chrome Leon, Business Analytics, Middle wares etc.
- Hands-on experience on testing tools like Client ALM, Knit and SNOW .
Validation expert for Manufacturing Equipment qualification
Candidate will be accountable for authoring Validation Plan, and Validation Summary Reports and have fair understanding on other SDLC documents. Client/DCS Integrated with Manufacturing Equipment qualification. Candidate will provide an application validation expertise practically on different scena...
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