Anil Babu Jagarlamudi Email & Phone Number

Self-motivated, Senior Specialist with 15 years of experience in Quality Assurance in Biopharmaceutical /Pharmaceutical industries, Complex injectables, Oncology and combination products. Proven to successfully design and implement quality systems and drive positive change in fast paced environments. Decisive leader who will apply initiative and innovation to establish and sustain successful performance both as individual contributor and team player. Maintain strong verbal and written communication with employees at all levels. Proficient with Veeva (QMS & RIMS vaults), Trackwise, Document compliance manager (EDMS & SDMS), SAP, LIMS, LMS, Workday and Microsoft Office. I do my best work in challenging situations.Specialties:Strong working knowledge of FDA, EU-GMP, PICS, PDA, ISO, ICH, ISPE, 21 CFR Part 210, 211, 600-680, 820, Part 4 and Part 11, ISO 13485, ISO 14971 requirements. Quality Management systems; Change management, Deviation management, Investigations, CAPA, Complaints, Technical writing, Aseptic processing, Terminal sterilization, Lyophilization, Prefilled Syringes, Suspensions, Emulsions, microspheres, Nanoparticles, ophthalmic, and Risk management (FMEA).

Listed skills include Cleaning Validation, Aseptic Process Validations, Sterility Assurance, Quality Management, and 13 others.

• 

  S.S.N.P.G.College, Nagarjuna University

  69%