Amit Garg
Site Quality Head at Aurobindo Pharma Ltd
- Role
- Site Quality Head at Aurobindo Pharma Ltd
- Location
- Hyderabad, IN
- LinkedIn followers
- 500 followers
About Amit Garg
Worked at Sr Positions of Quality functions (QA/QC) in reputed organisations like Claris Lifesciences, Capsugel India, Strides Arco lab, Radicura Pharmaceuticals, Ess Jee Pharmaceuticals specialized in sterile & Non sterile formulation tablets, soft & hard gelatin capsules, injectables. Regulatory Audits Faced: US-FDA, UK-MHRA, SA-MCC, Aust- TGA, Brazil-ANVISA, and WHO- GMP. 30 yrs of experience in Quality Operations (QC/QA) of dry powder sterile Injectables, liquid Injectables,Oral Liquids, Tablets, Capsules, dosage forms with experience of new manufacturing facility validations & qualifications of clean rooms, equipments, audits, trainings etc. Personal Attributes: Team player dedicated to quality and continuous improvement. Strong communication, technical, and interpersonal skills, and demonstrated project management capabilities. Provided leadership and mentoring to the fellow team members in their carrier development. I Can, I will Attitude. Specialties: •Review of technical dossiers for international market. •Review of dossiers, validation protocols and study reports. •Ensure the implementation of GLP/GDP in the operation of laboratory.Stability Studies, Risk Assessment,Quality Management Professionally qualified, hardworking, team leader with sound technical skills and having interests towards keeping abreast of the developments and the latest trends QA/QC & Regulatory affairs in Pharma industry. liaison with local FDA regulatory bodies.
Experience
Site Quality Head
Aug 2018 — Present · Hyderabad, IN
Currently heading as Quality Head for dedicated facility manufacturing OSD formulations, sterile injectables for regulatory and Latin countries.
Education
M.D.University Rohtak. Haryana
Master's Degree
1984 — 1986
ALL India Institute of Management, Chennai.
PGDIM
Skills
- Validation
- 21 Cfr Part 11
- Manufacturing
- Quality Management
- Gxp
- Sop
- Gmp
- Formulation
- Anda
- Fda
- Glp
- Continuous Improvement
- Quality System
- Technology Transfer
- Regulatory Submissions
- Regulatory Affairs
- Computer System Validation
- Quality Assurance
- Quality Auditing
- Aseptic Processing
- Cleaning Validation
- V&V
- Quality Control
- Sterilization
- Pharmaceutical Industry
- Capa
- Change Control
- Regulatory Requirements
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.