AZJP 37 CSV Engineer Trinity Consultants

0.0 - 5.0 years

4 - 8 Lacs

Visakhapatnam, Hyderabad

Work from Office

Job Description The scope of work for this role is to provide QA Validation support to validation activities associated with of Laboratory instruments and Manufacturing equipment in pharmaceutical industry. The responsibility includes review and approval of Qualification/Validation documentation DQ,IQ,OQ,PQ including Risk assessment, specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls. In addition, this role may provide support to the sites data integrity initiative. Successful candidate requires a strong working knowledge of global cGMP with an emphasis on validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures Candidate requires strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QA Validation/Qualification personnel. Candidate must be detail oriented as the main job responsibility is review and approval of validation documentation Should also have some experience in Mechanical Qualification Job Requirements Skills: Strong working knowledge of global GMPs with emphasis on validation, including computer validation Strong interpersonal, oral and written skills Detail oriented Education: Candidate must have at a minimum a BE or equivalent, engineering or related sciences with pharmaceutical or biopharmaceutical experience in a quality assurance and/or validation/Qualification role. Past experience working with Equipment Qualification, Quality Management system, Document, Document Management System, Track wise, and etc. Experience working with process manufacturing equipments (RMG, Sifter, Blender, compression m/c, Capsule filling m/c & etc), Utility (Water system, HVAC & etc) and other lab instruments is a plus.

Posted 2 weeks ago

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Labs Tech Lead Teamlease Digital Private Limited

10.0 - 15.0 years

14 - 15 Lacs

Remote, , India

Remote

Job Description REMOTE OPPORTUNITY!!!!!!!! Client: Technology GCC for Global Biotech Company 2+ years of relevant experience in leading teams in the development and support of IT systems Development in a GxP biotech or pharmaceutical environment 2+ years of process improvement experience, especially experience that leverages technology as part of the solution. 2+ years experience working in a regulated environment with knowledge of GMPs, GDPs. Exceptional Interpersonal, Verbal and Written Communication Strong Leadership Skills Including Ability to Inspire and Motivate Team Members Ability to Keep Track of Various Activities in Multiple Systems Task Delegation Strong Analytical / Problem-Solving Abilities Software Design and Development Test Script Writing and Execution Business Analysis Knowledge and Understanding of 21 CFR Part 11 and Data Integrity

Posted 4 weeks ago

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AZJP 37 CSV Engineer Trinity Consultants

- 5 years

4 - 8 Lacs

Visakhapatnam, Hyderabad/Secunderabad

Work from Office

Posted 2 months ago

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