Validation Expert
6 days ago
Agile or DevOps methodology. The successful candidate shall possess:
- Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., 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 i.e., 21CFR Part 11, EU annex 11, and Guidelines e.g., GAMP5 guide.
- OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)
- PAS/DCS Qualification
- ISA95 High level of understanding
- OT Security will be a plus.
- Standalone Systems Qualifications
- PAS/DCS Integrated with Manufacturing Equipment qualification.
- 10 to 12 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 i.e., LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc..
- Hands-on experience on testing tools like HP ALM, Kneat and SNOW
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Indianapolis, IN, United States ClifyX Full timeMandatory skills* Well versed with Manufacturing, Quality and engineering system and their validations. OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus), Client/DCS Integrated with Manufacturing Equipment qualification . Desired skills* OT System Qualification (Radio ligand Therapy or critical dosage forms will be a...
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Indianapolis, IN, United States ClifyX Full timeMandatory skills* Well versed with Manufacturing, Quality and engineering system and their validations. OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus), Client/DCS Integrated with Manufacturing Equipment qualification . Desired skills* OT System Qualification (Radio ligand Therapy or critical dosage forms will be a...
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Indianapolis, IN, United States ClifyX Full timeMandatory skills* Well versed with Manufacturing, Quality and engineering system and their validations. OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus), Client/DCS Integrated with Manufacturing Equipment qualification . Desired skills* OT System Qualification (Radio ligand Therapy or critical dosage forms will be a...
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Indianapolis, IN, United States ClifyX Full timeMandatory skills* Well versed with Manufacturing, Quality and engineering system and their validations. OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus), Client/DCS Integrated with Manufacturing Equipment qualification . Desired skills* OT System Qualification (Radio ligand Therapy or critical dosage forms will be a...
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