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Laxmi Gopal

Chemist rnd

540 followers

Andhra Pradesh, India

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Timeline
Skills
Quality assurance
Quality system
Gmp
Pharmaceutical industry
Microsoft office
Fda
Sop
Technology transfer
Supply chain management
Pharmaceutics
Regulatory requirements
Ms office
Dia training attended
Quality systems
Microsoft excel
Validation
Auditing
Capa
Glp
About me
Faced 2 FDA Audits,1 TGA Audit,2 EDQM and PMDA i.e JAPAN Regulated Audit Specialties: Trainer for GMP activities
Education
- College
  -
  M.Sc chemistry
- Z P H school
  1986 - 1991
  Tenth class
- Andhra University
  1993 - 1996
  Bachelor of science Chemistry
Experience
- ALMELO CHEMICALS PRIVATE LIMITED
  Jan 1998 - Nov 2001
  Chemist rnd
- Andhra sugars ltd
  Sept 2003 - Mar 2005
  Chemist
  worked as production chemist
- Wanbury Limited
  Mar 2005 - Apr 2009
  Sr. Executive
  works nearly 5 yrs.Faced USFDA Audit at Feb 2009 and EDQM at Apr 2009
- Hetero Drugs Ltd
  May 2010 - Jul 2011
  Asst. Manager-QA
  Faced $ regulated audits i.eUS FDA Audit, TGA Audit, EDQM and PMDA(Japan Regulated audit) and sutomer audits.
- Chiral Biosciences Limited
  Aug 2011 - Apr 2013
  QA-Manager
  worked as Manager-QA
- Emmennar Pharma Private Limited
  Jun 2013 - Aug 2018
  Quality Assurance Manager
- Laurus Labs Limited
  Sept 2018 - now
  Quality Assurance Manager
Licenses & Certifications
- Valudation aspects in pharmaceutical sector
  Government of Andhra Pradesh,dca
  Feb 2016
- WHO-EDQM-DIA workshop on Quality of API
  Drugs Information Association
  Sept 2011
  View certificate
- CGMP Data Integrity
  I3R Global - B2B Marketing Company
  Dec 2015
  View certificate

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