ANKIT KHIMANI
Surat
Summary
Diligent and dedicated with 15+ years of experience in the industry. Excellent interpersonal and communication skills. Dynamic and determined with exceptional leadership qualities.
Overview
16
16
years of professional experience
Work History
Deputy Manager - QA
CTX Life Sciences Pvt. Ltd.
12.2013 - Current
- Responsible for audit and compliance activity viz. Regulatory audit, customer audit and its responses/compliance report (direct handling since 2018).
- Working as team leader/group leader and leading key QMS activities (but not limited to) like change control, deviation, validations (PV & CV), IPQA, Return goods/recall, process risk assessment, nitrosamine risk assessment, SOPs review/approval, CSV activities, transport validation, batch release activity, etc.
- Managing customer affairs like customer questionnaire, review and approval of technical quality agreement with customers, handling of customer query and provide other require support to customer etc.
- Responsible for vendor/supplier qualification and certified auditor for vendor audit.
- Certified internal auditor and presenter/coordinator of QMR meeting.
- Certified trainer for GMP trainings as well as departmental training.
- Review and approval of QMS documents viz. change control, deviation, returned goods, product recall and CAPA.
- Review and approval of equipment qualification documents, preventive maintenance, calibration and other engineering documents.
- Review and approval of process validation and cleaning validation documents.
- Review/approval of product quality review, batch manufacturing record, equipment cleaning record, SOPs, site master file, validation master plan, quality manual, CoA, other documents as applicable.
- Reporting to vice president Quality & RA
Executive–QA
RPG Life Sciences Ltd.
08.2012 - 11.2013
- Handling of change control, deviation, customer complaints/return goods.
- Handling of dispatch activity.
- Equipment and HVAC qualification.
- BMR review and batch release.
- APQR preparation.
Officer–QA
CTX Lifesciences Pvt. Ltd.
03.2009 - 08.2012
- Review of Equipment Qualification and HVAC qualification.
- Handling of engineering related change control and other engineering related documents.
- IPQA activity like line clearance, BMR review, ECR review for batch release.
- Preparation and Review of Process Validation Protocol and Report.
- Dispatch activity and CoA preparation.
- APQR preparation.
- Issuance and retrievals of documents like SOPs, BPCR, MPCR, ECR, Specification and Method of Analysis, Formats of concern department.
Trainee. Officer–QA
Mangalam Drugs & Organics Ltd.
10.2008 - 02.2009
- Issuance and retrievals of documents.
- BMR review, Data entry for APQR.
- Dispatch activity like labeling, sealing, CoA preparation etc.
Education
Master of Science - Organic Chemistry
Department of Chemistry, VNSGU
Surat, Gujarat, India04.2008
Bachelor of Science - Chemistry
P. T. Sarvajanik College of Science
Surat, Gujarat, India04.2006
Skills
- Good communication and well co-ordination skill
- Capable for handling and adopting of different professional situations
- Decision-making capabilities
- Positive Attitude and Teamwork
- Performance Improvements
- Staff Training and Development
- Strategic Planning
- Team motivation
- Problem Resolution
Accomplishments
- Health Canada (Remote GMP inspection, February 2022)
- USFDA audit (August 2022, February – 2019, January – 2018)
- EMA audit (September 2022)
- ANVISA, Brazil (November 2022)
- NDA, Uganda (April 2023)
Got opportunity to work independently as key auditee during regulatory authority inspections at CTX since 2018 to till this period of time:
Handling 40+ customer audits per year and its response.
Awarded by Managing Director of CTX in year 2021 for independent handling of entire activities of QA and successful completion of various customer audits during outbreak of COVID-19.
Committee member for Nitrosamine impurity assessment and N-Nitroso impurity assessment and successfully completed assessment for 27 APIs.
IT Expertis
- Command over operating system MS Office, SAP-ERP
- Complete the computer course “Certificate for Computer Concept” With “A” Grade in Sep-2011 from Spectrum Educational Institution, Surat.
- Complete the computer course “Certificate of MS Office-2007” With “B+” Grade in Dec-2011 from Spectrum Educational Institution, Surat.
- Complete the computer course “Certificate for Internet” With “A” Grade in Dec-2011 from Spectrum Educational Institution, Surat.
Languages
English
Advanced (C1)
Hindi
Advanced (C1)
Gujarati
Bilingual or Proficient (C2)
Timeline
Deputy Manager - QA
CTX Life Sciences Pvt. Ltd.
12.2013 - Current
Executive–QA
RPG Life Sciences Ltd.
08.2012 - 11.2013
Officer–QA
CTX Lifesciences Pvt. Ltd.
03.2009 - 08.2012
Trainee. Officer–QA
Mangalam Drugs & Organics Ltd.
10.2008 - 02.2009
Master of Science - Organic Chemistry
Department of Chemistry, VNSGU
Bachelor of Science - Chemistry
P. T. Sarvajanik College of Science
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