TD NEWTON
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Computer System Validation Engineer - Life Science Domain (3-12 yrs) Bangalore
Location:
Bangalore
Description:
Your key responsibilities :Technical Excellence :- Perform assessments of computer systems and processes for Life Sciences clients (compliance with internal procedures, leading practices, and regulatory requirements)- Create/review CSV deliverables like user requirements, system specifications, Validation Plan, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability matrix, Design Specs, and validation summary reports- Provide guidance and oversight of validation activities for projects involving GxP relevant computer systems- Work closely with project team members to incorporate appropriate elements of quality and compliance into the system lifecycle- Review and approve computer system validation work products, assuring thoroughness of validation planning and making appropriate progress towards timely completion of validation deliverablesSkills and attributes :To qualify for the role you must have :- Experience in Quality and Compliance with hands-on computer system validation experience on Enterprise Applications (SAP ECC/HANA, LIMS, QMS, ELN, DMS, PLM, CRM, CTMS, RPA etc.) - Experience in FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk based validation.- Experience with validation/ testing tools like HPALM, Azure DevOps (ADO) etc. will be an added advantage.- Experience in training validation resources will be an added advantage.Qualification :- A graduate degree from a reputed UniversityExperience :- 3 to 12 years of experience What we look for :- People with the ability to work in a collaborative manner to provide services across multiple client departments while following the commercial and legal requirements. - You will need a practical approach to solving issues and complex problems with the ability to deliver insightful and practical solutions. - We look for people who are agile, curious, mindful and able to sustain positive energy, while being adaptable and creative in their approach. (ref:hirist.tech)
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More About this Listing: Computer System Validation Engineer - Life Science Domain (3-12 yrs) Bangalore
Computer System Validation Engineer - Life Science Domain (3-12 yrs) Bangalore is a Engineering Validation Engineer Job at TD Newton located in India. Find other listings like Computer System Validation Engineer - Life Science Domain (3-12 yrs) Bangalore by searching Oodle for Engineering Validation Engineer Jobs.
Computer System Validation Engineer - Life Science Domain (3-12 yrs) Bangalore is a Engineering Validation Engineer Job at TD Newton located in India. Find other listings like Computer System Validation Engineer - Life Science Domain (3-12 yrs) Bangalore by searching Oodle for Engineering Validation Engineer Jobs.