Venkatesh J

Experience

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  Juggat Pharma

  Mar 2003 - Feb 2005

  Quality Control Chemist

  • Revamped stability studies for Drug substances (API) and Drug products as per ICH guidelines. • Oversaw analytical records and raw data for their accuracy and authenticity. • Ensured the calibration of instruments as per schedules. • Reviewed MMRs and executed BMRs for exhibit & commercial batches. Ensuring cGMP, GLP and required SOPs are met during manufacturing,

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  Wexford Laboratories

  Feb 2005 - May 2009

  Quality Control Executive

  • Standardized the Analysis of Raw Materials, In-process and finished Products as per monographs.• Supervised Method Development and method validation by using HPLC and UV-Spectrometer.• Spearheaded the Quality Control team.

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  LGC Promochem

  May 2009 - Oct 2011

  Scientist

  • Supervised the analysis of starting materials, intermediate and finished molecules used for the synthesis of Certified Reference Materials (CRM) for USP, EP.• Mapped the structural elucidation of target molecules• Devised method development and method validation for new molecules using LCMS, GCMS, HPLC, CHNS-O etc.• Streamlined laboratory for GLP compliance and prepared protocols as per requirements.

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  TUV SUD South Asia

  Nov 2011 - Jan 2016

  Supervisor

  • Streamlined the laboratory for GLP compliance as per ISO 17025. • Performed method validations for new methods by using LCMS-MS, GCMS, GC-ECD, UPLC, HPLC etc for Quantitative analysis.• Calibration of instruments as per the approved schedules. • Upgrading the existing employees for personality development to improve the efficiency for effective output. • Conducting an Internal audits as per ISO 9001:2000, ISO 17025 etc.

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  PD Navkar bio-chem pvt ltd

  Sept 2016 - Aug 2017

  Quality Manager

  • Management of key quality systems elements viz., Regulatory, Customer audit Compliance, Change control, Deviation, Non-conformances, CAPA, Vendor audit, Market complaints, OOS, OOT, Process validations, product quality review, GMP/GLP Training, facility/equipment qualification, calibration etc.• Review and implementation of Quality systems documents like Site master file, Master validation plan, Quality manual, Data Integrity Policy and Standard Operating Procedures, Team Handling.• Responsible for self-inspection (Internal Audits) management at site and to ensure self-inspection of all quality systems & sub systems are performed in accordance with established SOPs• Preparation and review of validation protocols, reports, apex documents and departmental SOPs etc. Show less

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  SHARON BIO MEDICINE

  Sept 2017 - now

  Sr. Manager Corporate Quality Assurance (CQA)

  •• Spearhead, support and report independent GMP audits according to the Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations. The audits performed include internal and external manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses and suppliers etc.• Having exposure to face Regulatory as well as customer audit. like USFDA, ANVISA, Health Canada etc. • Ensure appropriate escalation to responsible stakeholders in case of critical findings and support immediate follow-up measures according to relevant procedures in compliance with cGMP/GLP, the Quality Technical Agreement, regulatory requirements, Quality Manual and established SOPs.• Provide QA oversight and confirms adequate GMP compliance at the manufacturing units for new and current products including process validation, master documentation approval and the implementation of quality agreements and Participation in due diligence data review.• Author, review and/or approves change controls, deviations, CAPA, vendor qualifications and other QMS documents raised at corporate level.• Review and approve artworks of new products/modified products and ensure that only current artworks are used.• Communicate customer notifications as needed Implement and sustain QMS across the organization Show less