Computer System Validation Compliance Coordinator required in APOTEX RESEARCH
Apotex Research Pvt. Ltd. is a wholly owned subsidiary of Apotex Inc. Canada which is a number one generic pharma co. in Canada. The position is for Bangalore location which has an R&D Centre, Manufacturing and a Bioequivalence Centre.
Post: CSVC [Computer System Validation Compliance]Coordinator
• Perform validation activities for computer applications in coordination with IS, Business users and CSVC-Canada (when required)
• Ensuring the implementation of Apotex CS-VMP and other Apotex corporate quality policies and Regulatory guidelines
Professional Experience: At least 2 years overall experience with at least 1 year from QA environment of Pharma domain
• Knowledge on software implementations and validations (Installation, Operational and Performance Qualifications)
• Good documentation skill especially computer system validation related
• Knowledge on Pharma applications like LIMS, Chromatography Data Systems etc.,
• Knowledge on GMP, GaMP etc., practices
• Knowledge on FDA etc., guidelines
Experience: 2-5 years
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: IT
Contact: Apotex Research Pvt Ltd
Site No.1 Bommasandra Indl Area,
4th Phase JiganiLink Road,560001.
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