Vinod Kumar
Gangtok
Summary
To secure a challenging role in a dynamic FDA-approved pharmaceutical manufacturing facility, leveraging my extensive experience in Quality Assurance and IPQA operations to uphold regulatory compliance, drive process excellence, and contribute to the production of safe, effective, and high-quality products
Overview
15
15
years of professional experience
Work History
Head-Operations IPQA
Sun Pharmaceuticals
09.2024 - Current
- Leading and managing a team of 34 IPQA professionals across four formulations: Tablets, Capsules, Dry Powder Inhalers (DPI), and Soft Gelatin Capsules, metered dose inhalers and form fill sealed(ffs) sterile.
- Oversight and approval of key quality systems: Deviation, Change Control, CAPA, APQR, Complaint handling, and Product Recall processes.
- Investigation and disposition of OOS/OOT results, ensuring thorough root cause analysis and timely closure.
- Driving GMP compliance across shop floor activities through active monitoring, documentation control, and audit readiness.
- Audit representative for operations during regulatory inspections (External, FDA, CDSCO, WHO, etc.) and customer audits.
- Conducting and leading internal audits as a certified auditor, ensuring cross-departmental compliance with established SOPs and regulatory guidelines.
- Championing simplification and continuous improvement projects to streamline IPQA processes and reduce quality events.
- Facilitating corporate communication between the site and global quality teams to ensure alignment on quality standards and initiatives.
- Leading batch release support through real-time in-process monitoring, line clearance, and documentation review.
- Initiating and managing product recalls, ensuring traceability, risk assessment, and regulatory communication.
- Acting as a certified trainer, delivering technical and compliance-based training modules for IPQA staff and cross-functional teams.
- Supporting technology transfer and process validation activities for new product introductions.
- Leading Quality Risk Management (QRM) sessions to assess and mitigate risks across manufacturing processes.
Team Lead-QA(Manager)
Cipla Limited
08.2014 - 09.2024
- Responsible for the decision-making process in all matter that affect the quality of products including development, Production, Laboratory, Storage, Distribution, Vendors and Third-Party Contractors.
- Management review meetings, site quality council meetings & documentation.
- Review & approval of Master Documents: BMR/BPR, Specifications, STPs, SOPs, Qualification/Validation protocols & reports.
- Ensure Investigation of Out of Specification, Out of Trend, Rejection, Batch Failures, Process and Procedure Deviation and Batch failures are appropriately performed and documented.
- Ensure the review of annual product quality report of all drug products and its relevant data / records to assure that products are meeting consistently quality standards.
- To establish a system to release or reject all starting materials, Finished Products, Raw Material, Packaging and Labelling materials etc.
- Conducting self-audits, regulatory audit compliance & CGMP quality audits that regularly appraises the effectiveness and applicability of the quality assurance system.
- To ensure evaluation and Approval/ Evaluation /Rejection of change control related to system, facility, product and document and study of impact related to changes.
- Approval of unit SOPs, document of quality function, validation protocols /report, layouts /plans, Organization charts, documents of quality function.
- To ensure that the required initial and continuing training of department personnel is carried out as per the SOP Timeline.
- Keeps informed of existing and proposed FDA regulation relating to assigned responsibility, appraised their effect on company operations and sees that appropriate action is taken to assure compliance with FDA Regulator and compliance for various regulatory agencies.
- To ensure the sourcing of material, manufacturing and testing is carried out as per dossier, accepted for registration by concern regulatory agency. Preparation of documents required for regulatory affairs.
- To assure that appropriate calibration and preventive maintenance of manufacturing equipment and laboratory instruments are conducted as scheduled and record thereof is maintained.
- Attend to all customer /regulation audits and compliance and response to audit observation.
- Be notified of all circumstances which may affect the quality of products, whether before or after release for sale /supply.
- Ensure investigation of recalled /returned products.
- To monitor returned goods, rework procedures, salvage and approve disposition.
- Ensure investigation of product complaints monitoring and addressing queries related to product quality issued.
- To assure that all validations are properly planned, executed, and documented.
- Monitor qualification of new /modified areas /equipment and also ensure there re- qualification.
- To evaluate and approve /reject of any reprocessing and reworking of products.
- Ensure review of technical agreement and quality agreement.
- Ensure that there is stability data to support retest or expiry dates /best before date and storage condition of drug substance, intermediate and drug product.
- To ensure and monitor compliance with GLP and cGMP as per requirements of the respective authority.
- Review of Hold Time Study protocols, Stability Grid & CQA SOPs.
- Management review meetings, site quality council meetings & documentation.
Team Member IPQA operation
Intas Pharmaceuticals Limited
11.2010 - 08.2014
- To carry out in-process samples during granulation, compression, capsule filling, coating & Packaging operation.
- To ensure line clearance during manufacturing & packing operation.
- To review and ensure batch and cGMP Documentation gets filled on real time basis.
- To execute calibration of all IPQC lab instruments as per schedule.
- To review in-process results & to ensure result compliance with standard specification.
- Continuous vigilance to ensure conformance to SOPs manufacturing instructions & prevention of risk through the plant to avoid mix-ups & cross contaminations.
- Handling of online rejection and review of online BMR&BPR.
- Dispatch of finish product as per procedure.
- Conducting monthly training to workers, production Associates to achieve desired Quality level.
- Coordination with QC, Production, store packing and administration to produce safe pure and effective product.
- Issuance of BPR and BMR as per SOP.
- Participate in HVAC validation and Compressed air validation.
Education
High school -
UP board
01.2003
Bachelor of Pharmacy -
H. C. P. G. Varanasi
01.2010
Intermediate -
UP Board
01.2005
Skills
- Skilled in creating documents and presentations using MS Office
- Proficient in Windows operating systems
- SAP software expertise
- Progress monitoring
- Cipdox application skills
- EDLMS integration expertise
- Skilled in digital log management
- Tantra software proficiency
- Cleen
- Adaptability to diverse environments
- Team formation expertise
- Sound judgment skills
- Strategic decision making
Accomplishments
- Successfully reduced deviation closure timeline by 30% through root cause trend analysis and workflow optimization.
- Led the successful completion of 8+ regulatory and customer audits with zero major observations related to IPQA.
- Initiated and implemented a 'Quality Simplification Project' that led to a 25% increase in operational efficiency and reduced documentation burden.
- Spearheaded digital IPQA logbook transformation, reducing manual errors and improving traceability.
- Developed and deployed a training matrix and certification program for 34 team members, improving audit readiness and staff competency.
- Played a key role in the tech transfer and commercial launch of 5+ products across various dosage forms.
- Initiated recall drills and mock audits, improving cross-functional response time by 40% during real recall scenarios.
- Recognized by corporate quality leadership for exemplary audit preparedness and proactive risk mitigation strategy.
Project
SCADA (EDLMS), Atomization project for Online data generation, collection, Storage from the Equipment. Tantra software, Inproces data control software. E_Log, Online daily log book entry through the system.
Audit Faced
- WHO-CDSCO (5 Times)
- Food Safety Management- ISO 22000-2018
Personal Information
- Date of Birth: 12/20/86
- Nationality: India
- Marital Status: Married
Formulation Exposure
- Tablets
- Capsules
- Dry Powder Inhalation (Rotacaps)
- Metered Dose Inhalers
- Form fill sealed(FFS) formulation
Languages
English
Advanced (C1)
Timeline
Head-Operations IPQA
Sun Pharmaceuticals
09.2024 - Current
Team Lead-QA(Manager)
Cipla Limited
08.2014 - 09.2024
Team Member IPQA operation
Intas Pharmaceuticals Limited
11.2010 - 08.2014
Bachelor of Pharmacy -
H. C. P. G. Varanasi
Intermediate -
UP Board
High school -
UP board