Validation Expert
7 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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Director, Compliance and Validation
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Indianapolis, IN, United States Barry-Wehmiller Companies Inc Full timeAbout Us: BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine...
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Director, Compliance and Validation
5 days ago
Indianapolis, IN, United States Barry-Wehmiller Companies Inc Full timeAbout Us: BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine...
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Delivery Expert
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Indianapolis, IN, United States Domino's Pizza LLC Full timeCompany Description As a Delivery Driver for MRF, you will be the face of our company to our valued Customers. You will have the opportunity to be a part of every aspect of store operations and receive daily tips. Your interactions with Customers are crucial in creating a positive experience and putting a smile on their face. Your positivity and...
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Delivery Expert
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Indianapolis, IN, United States Domino's Pizza LLC Full timeCompany Description As a Delivery Driver for MRF, you will be the face of our company to our valued Customers. You will have the opportunity to be a part of every aspect of store operations and receive daily tips. Your interactions with Customers are crucial in creating a positive experience and putting a smile on their face. Your positivity and...
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Delivery Expert
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Indianapolis, IN, United States Domino's Pizza LLC Full timeCompany Description As a Delivery Driver for MRF, you will be the face of our company to our valued Customers. You will have the opportunity to be a part of every aspect of store operations and receive daily tips. Your interactions with Customers are crucial in creating a positive experience and putting a smile on their face. Your positivity and...
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Delivery Expert
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CSV Engineer
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Indianapolis, IN, United States Katalyst HealthCares & Life Sciences Full timeJob Title Responsibilities: Interface with client Subject Matter Experts, Site and Area Management, Quality Assurance, and other stakeholders for validation planning. Guide the creation and updates of project validation planning deliverables such as Validation, Security, and Test Plans. Support execution of validation activities in alignment with the...
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CSV Engineer
2 weeks ago
Indianapolis, IN, United States Katalyst HealthCares & Life Sciences Full timeJob Title Responsibilities: Interface with client Subject Matter Experts, Site and Area Management, Quality Assurance, and other stakeholders for validation planning. Guide the creation and updates of project validation planning deliverables such as Validation, Security, and Test Plans. Support execution of validation activities in alignment with the...