VISHAL KOTAK
Ahmedabad
Summary
- Performance driven professional with 12+ years of rich and extensive experience in QA, Manufacturing Compliance, Oversight QA, Audit & Compliance, Training, Investigations, Supplier Quality, Technology transfer.
- Certified Investigator for Quality events.
- Created curricula, instructions, modules and tests for training courses.
- Possesses strong research, analytical, problem solving and interpersonal communication expertise.
- Skilled in interfacing with cross functional & cross cultural teams for improving various quality concerned aspects.
- Highly proficient in complex formulation design and managing routine challenges; Injectable (Vial, PFS, Ampoule, SVP, LVP) Nasal, Aerosol, Trans Dermal, Solid orals, DPI.
- A Strategist with recognized proficiency in accomplishing corporate plans and business goals successfully.
- Hands on experience in Audits: Regulatory Agencies (USFDA, MHRA, ANVISA, TGA, EU GMP, MCC, Health Canada etc.), Global Business partners (Pfizer, Zoetis, GSK, Cipla, Zydus Cadila etc.)
Overview
12
12
years of professional experience
Work History
Senior Manager, Quality Assurance and Compliance
INTAS PHARMA
Ahmedabad
09.2023 - Current
- Led initiatives to foster a company-wide quality assurance culture.
- Analyze training needs for organization and individuals; Planned and delivered training sessions to improve employee effectiveness and address areas of weakness.
- Managed Quality Management System and Compliance.
- Implemented and maintained a data governance culture, setting the regulatory framework.
- Structured regulatory audits and responses.
- Review and compile regulatory audit observations and prepared responses, tracking the compliance status.
- Developed site inspection readiness plans to ensure the site is always ready for regulatory inspection and able to continue supply quality products.
- Management and handling of Internal Audit, Corporate Audit.
- Demonstrating effective leadership.
Manager, Quality Assurance and Compliance
Pfizer Healthcare India Pvt Ltd.
Ahmedabad
10.2015 - 09.2023
- Handling regulatory audit (Virtual and Onsite) planning and preparation. Review and compilation of regulatory audit observation, response preparation and tracking for actions.
- Lead site Inspection readiness plan, ensuring constant preparedness for regulatory audits.
- Certified trainer; Assisted in analyzing and assessing training and development needs for organizations, departments and individuals.
- Certified Investigator; Responsible for review and approval for Deviation, Laboratory Investigations, Market complaint, Corrective and Preventive action, Change control. Managed the Preparation and submission of Field Alert Report (FAR) and Regulatory agency notification for the quality issues.
- Management of the supplier life cycle management including Supplier audit, QTA and CAPA tracking. Providing quality support for alternate API Program and New Product launches.
- Conducting risk assessment using tools like FMEA.
- Ensured compliance of electronic data w.r.t. 21 CFR part 11, part 211, GAMP 5 guideline, EU annexure 11, MHRA, USFDA and PICS data integrity guideline, ICH guideline etc.
- Implemented policies and procedures related to CSV such as URS preparation, Traceability metric, User Management Configuration, Electronic Signature policy, Password policy, Data Interface, Data Migration, Disaster Management recovery and Business Continuity Plan.
- Provide technical support to production team to enhance the process design and complied with regulatory requirement.
- Part of tech transfer team; To provide quality support
- Providing oversight quality support to foreign sites.
- Certifying Batches for commercial release.
Senior Officer Quality Assurance and Compliance
Amneal Pharma (SEZ, Injectable)
Ahmedabad
04.2015 - 10.2015
- Investigator for the Quality events. Conscripting and review of Site investigations (Deviation, Complaint, OOS and OOT).
- As an Internal Auditor, Leading site Inspection readiness plan to ensure site is all time ready for regulatory audit.
- Handling of Regulatory, Internal Audit and Audit compliance.
- Working as Training coordinator and technical trainer.
- Review and approval of the Technical / Quality agreement with Supplier / Service providers.
Quality Assurance Officer
Amanta Healthcare (Formally Known as Mark Bioscience)
Kheda
04.2014 - 04.2015
- Investigating and drafting, report for Market complaint, Deviation and Laboratory events.
- Initiating and reviewing Change Control, Temporary Change Control and Incident report.
- Handling of Regulatory and Customer Audit.
- Performing IPQA activities in order to ensure cGMP compliances.
- Certify line clearance for SVP and LVP.
- Preparation and review of Standard Operating Procedure for QA Dept.
- Review and Approval of Batch Manufacturing/Packing Records, Hold time Study report, Validation protocol-report, batch sampling plan.
Technical Supervisor- In Process Quality Assurance
ZYDUS CADILA
Ahmedabad
09.2011 - 04.2014
- Performing IPQA activities in order to ensure c GMP compliances and to certify line clearance.
- Batch release in SAP.
- Preparation and review of Annual Products Quality Report.
- Sampling of In-process, Finished product, Control Sample and Stability Sample and Verification of Physical parameter of Retain sample.
- Initiating and Reviewing Change control, Investigations.
- Co-ordinate with Validation team to perform the Validation / Qualification activity.
- Review and assessment of Alarm report.
Education
M Pharm - Pharmaceutical Quality Assurance
Smt. M N Padalia College of Pharmacy (Gujrat Technical University)
Ahmedabad04-2018
B Pharm - Pharmacy
Smt. V B Manavar Colleage of Pharmacy (Saurastra University)
Upleta, Rajkot06-2011
HSC - Science
Aadarsh School
Kadi03-2007
Skills
- INVESTIGATIONS
- QUALITY MANAGEMENT SYSTEM-QMS
- TRAINING AND DEVELOPMENT
- DATA INTEGRITY & COMPLIANCE
- IMPACT ASSESSMENT / RISK MANAGEMENT
- PROCESS SIMPLIFICATION & HARMONIZATION
- QUALITY ASSURANCE / CORPORATE QUALITY
- AUDIT AND COMPLIANCE
- SUPPLIER QUALITY
- MANUFACTURING COMPLIANCE
- TEAM MANAGEMENT
- 21 CFR PART 11 & 211
- AUTOMATION
- AUDITOR
- DATA DRIVEN DECISION MAKING
- PROJECT MANAGEMENT
Accomplishments
- Certified M1 Investigator and Trainer
- Certified Human Performance Investigator.
Personal Information
- Date of Birth: 01/08/1990
- Nationality: Indian
- Marital Status: Married
Languages
- ENGLISH
- HINDI
- GUJARATI
Languages
Gujarati
First Language
English
Advanced (C1)
C1
Hindi
Advanced (C1)
C1
Affiliations
- successfully convert an analog QMS system to an electronic one.
- Execute the Method one investigation tool (DMAIC Approach) successfully.
- Implement One best way (OBW) to enhance the technical writing skill.
PERSONAL DETAILS
Date of Birth : 08 Jan 1990
Nationality : Indian
Marital Status: Married
Timeline
Senior Manager, Quality Assurance and Compliance
INTAS PHARMA
09.2023 - Current
Manager, Quality Assurance and Compliance
Pfizer Healthcare India Pvt Ltd.
10.2015 - 09.2023
Senior Officer Quality Assurance and Compliance
Amneal Pharma (SEZ, Injectable)
04.2015 - 10.2015
Quality Assurance Officer
Amanta Healthcare (Formally Known as Mark Bioscience)
04.2014 - 04.2015
Technical Supervisor- In Process Quality Assurance
ZYDUS CADILA
09.2011 - 04.2014
M Pharm - Pharmaceutical Quality Assurance
Smt. M N Padalia College of Pharmacy (Gujrat Technical University)
B Pharm - Pharmacy
Smt. V B Manavar Colleage of Pharmacy (Saurastra University)
HSC - Science
Aadarsh School
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