ALPESHKUMAR PATEL
A-101, MALHAR THE LANDMARK, OPP. SAHAJANAND SCHOOL, NEAR BAPA SITARAM CHAWK, NAVA NARODA, AHMEDABAD
Summary
Dynamic professional with extensive experience in regulatory compliance and quality control at INTAS PHARMACEUTICALS LIMITED. Proven track record in leading teams of microbiologists, developing SOPs, and implementing process improvements. Adept at laboratory calibration and fostering staff development, ensuring operational excellence in microbiology laboratory settings.
Overview
22
22
years of professional experience
Work History
Assistant General Manager
INTAS PHARMACEUTICALS LIMITED
PHARMEZ, AHMEDABAD
2009.11 - Current
Ensured compliance with regulatory requirements in microbiology laboratory operations.
Supervised more than 70 microbiologists through various regulatory audits successfully.
Coordinated TMS/QMS activities such as CRF management and CAPA implementation.
Reviewed documentation for sterility testing and other quality control measures.
Prepared media and handled cultures for validation of autoclaves and HEPA filters.
Calibrated and operated laboratory equipment including TOC and microbial identification systems.
Performed environmental monitoring tests including air sampling and water testing procedures.
Developed SOPs and protocols for environmental monitoring and QA activities in parenteral area.
EXECUTIVE-QA
RUSAN PHARMA LTD
GANDHIDHAM, KUTCH
2008.12 - 2009.11
RESEARCH ASSOCIATE
ZYDUS CADILA LTD.
MORAIYA, AHMEDABAD
2007.06 - 2008.12
TECHNICAL SUPERVISOR-QC
CADILA PHARMACEUTICALS LIMITED
DHOLKA, AHMEDABAD
2005.04 - 2007.06
MICROBIOLOGIST-QA
CLARIS LIFE SCIENCE LTD.
CHANCHARWADI VASNA, AHMEDABAD
2004.03 - 2005.03
RESEARCH AND DEVELOPMENT-OFFICER
ANIL PRODUCTSLTD.
BAPUNAGAR, AHMEDABAD
2003.08 - 2004.03
Education
MASTER OF SCIENCE -
GUJARAT VIDHYAPITH
SADARA, GANDHINAGAR.2003-04
BACHELOR OF SCIENCE - MICROBIOLOGY
GUJARAT COLLEGE
ELLIS BRIDGE, AHMEDABAD.2001-04
HIGHER SECONDARY SCHOOL CERTIFCATEI -
VIDHYANAGAR HIGH SCHOOL
THAKKARBAPA NAGAR, INDIA COLONY, AHMEDABAD.1998-03
SECONDARY SCHOOL CERTIFICATE -
HOSANNA MISSION HIGH SCHOOL
VIRATNAGAR, AHMEDABAD.1996-03
Skills
- Regulatory compliance
- Quality control
- SOP development
- Laboratory calibration
- Process improvement
- Compliance auditing
- Technical supervision
- Problem solving
- Team leadership
- Procurement
- Inventory control
- Staff development
- Resource allocation
Affiliations
- Exposure to various consultants during the oversight of US batch manufacturing, such as Lachman, QXP, CBE, Quantic, Qualiculture and Validant.
- Involved in various training program by CBE, Lachman and QXP consultants for OOS, Investigation, Deviation, Aseptic Processing, Audit readiness and preparation.
Timeline
Assistant General Manager
INTAS PHARMACEUTICALS LIMITED
2009.11 - Current
EXECUTIVE-QA
RUSAN PHARMA LTD
2008.12 - 2009.11
RESEARCH ASSOCIATE
ZYDUS CADILA LTD.
2007.06 - 2008.12
TECHNICAL SUPERVISOR-QC
CADILA PHARMACEUTICALS LIMITED
2005.04 - 2007.06
MICROBIOLOGIST-QA
CLARIS LIFE SCIENCE LTD.
2004.03 - 2005.03
RESEARCH AND DEVELOPMENT-OFFICER
ANIL PRODUCTSLTD.
2003.08 - 2004.03
MASTER OF SCIENCE -
GUJARAT VIDHYAPITH
BACHELOR OF SCIENCE - MICROBIOLOGY
GUJARAT COLLEGE
HIGHER SECONDARY SCHOOL CERTIFCATEI -
VIDHYANAGAR HIGH SCHOOL
SECONDARY SCHOOL CERTIFICATE -
HOSANNA MISSION HIGH SCHOOL