Swaroop
Commissioning & Qualification -(Process Equipment) having knowledge with recent edition Regulatory guidelines UsFDA EUGMP, Annexure-11 &21 CFR Instrumentation And Computer system validation
- Role
- Assistant Manager at Biological E. Limited
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Swaroop
Engineering instrumentation & CSV and QMS Installation and commissioning of process and packing equipments Maintenance of all 21CFR equipment and operation Shift activities and Breakdown maintenance activities of process and packing machinery.Documentation work related to process machinery preventive maintenance and breakdown maintenance activities i.e: PM checklists, history cards.Exposure and Command on documentation work IQ, OQ and PQ and periodic revalidations of all process & packing equipments.Facing of Internal and External Audits.Implementation of all safety measure while working to avoid accidents.Maintaining GMP Documentation as per respective SOP.
Experience
Assistant Manager
Mar 2026 — Present · Hyderabad, IN
Engineering professional with over 8 years of experience in pharmaceutical and vaccine manufacturing. Specialist in instrumentation, automation troubleshooting, and Computer System Validation (CSV). Experienced in managing teams, handling data integrity compliance (21 CFR Part 11), and successfully facing major regulatory audits like the USFDA and MHRA.\" Overall 11 years of experience in engineering
Education
Sri Chundi Ranganayakulu Engineering College, Ganapavaram, Chilakaluripet, PIN-522 619(CC-90)
diploma, Electrical and Electronics Engineering
QIS Institute of Technology, Vengamukkapalem, Pondur Road, Ongole,PIN-523272(CC-MA)
Electrical and Electronic Engineering (EEE), Electrical and Electronics Engineering
2009 — 2012
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