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:
- Solid 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.

📌 Engineer - CSV (Hyderabad)
🏢 Trinity Consultants
📍 Hyderabad