NILESH KERKAL

Experience

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  Encore Healthcare

  Jun 2003 - Nov 2004

  Production Officer

  1) Handled Dispensing, Granulation, compression activities of Tablets and capsules.2) Performed Granulation, Blending, Lubrication and compression.3) Performed Inprocess checks and documentation.4) Involved in equipment qualification.

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  Cipla

  Dec 2004 - Sept 2006

  Officer in Quality Assurance

  1) Handled SOP review and implementation,3) Compilation of Process/ Cleaning validation protocol /Report.4) Sampling of process and cleaning validations.5) Implementation of VMP for the site.6) Involved in investigations

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  Shreya Life Sciences Pvt. Ltd.

  Sept 2006 - May 2007

  Senior Officer

  1) Involved in In-Process checks, 2) Handled IPQA activities and associated QMS tasks.3) Sampling of Process and cleaning Validation.4) Review of batch records.5) Participated in equipment qualification.

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  SUN PHARMA

  Jun 2007 - Feb 2008

  Senior officer in Quality Assurance

  1) Conducted review of Batch Documents & validation documents.2) Performed Product Assessment / validation studies,3) Involved ion sampling of Hold time establishment studies at various Manufacturing Stages.4) Involved in Deviations/ Change controls / Self-inspections activities.

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  Cipla

  Mar 2008 - Sept 2016

  1) Managed QMS section with team of 40+personnel.2) Led Market complaint group3) Expertise in investigations and CAPA implementation..4) Handled Change control, Deviations, Trending report. SOP review and approval.5) Experienced in FAR, Product Recall, OOS, OOT investigation.6) Successfully faced Regulatory inspections; USFDA, MHRA, WHO, TGA, IDA, IDMA, and INVISA Brazil, Russian GMP, FDA (India), and so on.7) Expertise in applying logical and scientific strategies for robust compliance.8) Presented Monthly Quality metrics/Reports to senior leadership. Show less 1) Expertise in root cause identification techniques for market complaints. 2) Applied adequate CAPAs controls to bring down the market complaints trend.3) Reduced the numbers of complaint year on year from 80% to 20%.4) Effectively led the team to complete timely investigations and responses.5) Worked as Quality representative of site to reach out to different cross functions for CAPA and compliance improvements.6) Expertise in trending and data analysis of complaints 7) Applied data based strategies /actions to reduce the complaints.8) Developed Interview questionnaire to identify specific human error. Show less 1 Managed Qualification & Validation Section 2) Handled relevant work allocation, monitoring and execution of VMP schedule.3) To Handle Market Complaints & Investigation.4) Ensured product & validation documents are in compliance for registration requirements 5) Effective implementation of Validation Master Plan, annual program of Qualification/ Validation.6) Conducted PPQ / Validation activities.7) Conducted impact assessment for major changes (i.e. Equipment change, API source change, Facility extension, Batch scale-up etc).8) Review, approval of Annual Product Quality Reports (APQR).9) Quality management review report.11Commerical Batch release/ Disposition for Regulatory market.12) Involved in Deviations/ Change controls / Self-inspections.13) Conducted training with Demonstration and monitoring on key activities. Show less

  • Lead for QMS and Audits Management

    Jul 2013 - Sept 2016

  • Team Lead of Market Complaints

    Feb 2011 - Jul 2013

  • Team Lead for Qualification and Validation / Quality Operations

    Mar 2008 - Feb 2011
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  Wockhardt Ltd.

  Sept 2016 - May 2022

  1) Planning scheduling of Audits.2) Conducted CMO Audits, Vendor Audits, Internal Audits, Market complaint investigations,3) Report writing /CAPA actions design, , follow-up and implementation and effectiveness monitoring.4) Expertise in total QMS activities (Change Controls, Deviations, Recall & FAR, Investigations, CAPA, APQR, Audit Compliance) 5) Led Regulatory inspections6) Competent in Electronic Data analysis including Audit trails, privileges review, recipe managements, alarms report.7) Equipments Qualifications and computerized systems qualification. 8) Risk assessments 9) Trainings on SOPs, and key systems. Show less

  • Senior Manager

    Dec 2019 - May 2022

  • Manager

    Sept 2016 - Nov 2019
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  Hetero

  May 2022 - now

  Assistant General Manager

  1) Operational compliance 2) Audit compliance3) QMS monitoring and implementation4) Vendor audits 5) Electronic data review6) Incident / complaint investigation and report review and responses.