Ravikant Yagnik
Edison,NJ
Summary
Experienced Process Engineer with extensive expertise in process validation and quality assurance at Amneal Pharmaceuticals. Proven track record in implementing continuous improvement initiatives and ensuring regulatory compliance. Skilled in mentoring teams and managing deviations, change control to optimize manufacturing processes. Committed to fostering collaboration and excellence in production operations.
Overview
13
13
years of professional experience
Work History
Process Engineer
Amneal Pharmaceuticals
Piscataway, New Jersey
06.2024 - Current
- Developed and executed process validation protocols.
- Designed cleaning validation protocols for topical, transdermal, and oral solid dosage formulations.
- Reviewed and improved batch manufacturing records, enhancing accuracy and compliance.
- Conducted comprehensive annual product reviews, ensuring sustained quality governance.
- Ensured adherence to ALCOA+ principles, promoting awareness among production personnel.
- Maintained compliance with standard operating procedures (SOPs) and performed online monitoring.
- Gained hands-on experience with Caliber QMAS and handled SAP transactions efficiently.
- Contributed to investigations, CAPA reviews, effectiveness checks, change control management, and PFMEA document evaluations.
- Analyzed process data to identify areas for efficiency improvement and cost reduction.
- Collaborated effectively with cross-functional teams to optimize regulatory compliance in operations.
- Reviewing and approving equipment qualification documents through ValGenesis.
- Internal audit team member.
- Developed standard operating procedures (SOPs) and trained staff on best practices.
- Managed the scale-up of new products from pilot to full-scale production.
QA (Biologics Injectables) Assistant Manager
Zydus Lifesciences Limited
Ahmedabad
02.2021 - 12.2023
- Performing in process and finished product quality checks of biologic's injectables.
- Review and release of Batch Manufacturing records and other process related documents.
- Execution of validation and exhibit batches.
- Ensuring compliance as per standard Operating procedures (SOP's) of manufacturing processes and online monitoring of the same.
- Production Floor related activities (Line Clearance, Sampling, Supervision of Packaging activity, deviation, investigation and CAPA implementation).
- Review of qualification documents, Monitoring equipment qualification activities.
- Adhering to ALCOA+ principles and creating awareness among production personnel's.
- Department training coordinator and Participating in internal and regulatory audits.
- Supervised day-to-day operations to meet performance, quality and service expectations.
- Lead in operational digitalization using CLEEN software.
- Hands on experience of LIMS, training software and handling SAP transactions.
- Established team priorities, maintained schedules and monitored performance.
- Assisted in organizing and overseeing assignments to drive operational excellence.
QA (Parenteral) Senior Executive
Puniska Healthcare Private Limited
Ahmedabad
05.2020 - 01.2021
- Performing in process and finished product quality checks of Injectables
- Execution of validation and exhibit batches
- Review of Batch Manufacturing records, Batch Packaging records and other process related documents
- Ensuring compliance as per standard Operating procedures (SOP's) of manufacturing processes and online monitoring of the same
- Production Floor related activities (Line Clearance, Sampling, Supervision of Packaging activity, deviation, investigation and CAPA implementation)
- Adhering to ALCOA+ principles and creating awareness among production personnel's
- Participating in internal and regulatory audits.
QA (OSD) Senior Executive
Amneal Pharmaceuticals Private Limited
Ahmedabad
02.2013 - 04.2020
- Performing in process and finished product quality checks of oral solid dosage forms
- Execution of validation and exhibit batches
- Review of Batch Manufacturing records and other process related documents
- Ensuring compliance as per standard Operating procedures (SOP's) of manufacturing processes and online monitoring of the same
- Performing Equipment Qualification that includes DQ (Design Qualification) IQ (Installation Qualification) OQ (Operational Qualification) PQ (Performance Qualification) and FQ (Facility Qualification)
- Preparing Qualification documents and reviewing the same
- HVAC (Heat, Ventilation, Air conditioning) system Qualification, preparation review of the protocols
- Preparation of Process Validation Protocols and Process validation reports and imparting trainings to the personnel involved in the execution of the validation batches
Education
Doctor Of Pharmacy (Pharm.D Post Baccalaureate) -
Rajiv Gandhi University of Health Sciences
Bangalore, India12-2012
Bachelor Of Pharmacy -
Rajiv Gandhi University of Health Sciences
Bangalore, India08-2009
Skills
- Process Validation and Quality Assurance
- Cleaning Validation
- Batch Record Review
- Regulatory Audit Preparation
- Advanced Process Optimization
- Root Cause Analysis
- Failure Mode And Effects Analysis
- Standard Operating Procedures
- Team mentoring and training coordination
- Cross-functional team leadership
- Training and development
- Change control management
- Deviation management
- Advanced Valgenesis and Caliber QAMS proficiency
Research Project
Prescribing Pattern of Antiepileptic Drugs in Adult in Tertiary Care Hospital Bangalore, 01/11, 09/11, Hospital Based Prospective and retrospective Observational Study On Inpatients. In our Study we found that Monotherapy is most frequently used in all types of seizures. Data shows that percentage of men suffering from epilepsy was higher than females.
Training
Pharmaceutical Industrial Training
Languages
English
Full Professional
Hindi
Full Professional
Gujarati
Native/ Bilingual
Affiliations
Music Enthusiast
References
References available upon request.
Timeline
Process Engineer
Amneal Pharmaceuticals
06.2024 - Current
QA (Biologics Injectables) Assistant Manager
Zydus Lifesciences Limited
02.2021 - 12.2023
QA (Parenteral) Senior Executive
Puniska Healthcare Private Limited
05.2020 - 01.2021
QA (OSD) Senior Executive
Amneal Pharmaceuticals Private Limited
02.2013 - 04.2020
Doctor Of Pharmacy (Pharm.D Post Baccalaureate) -
Rajiv Gandhi University of Health Sciences
Bachelor Of Pharmacy -
Rajiv Gandhi University of Health Sciences