Samirkumar Patel
Vadodara
Summary
Results-driven Cleaning Validation Specialist with extensive experience in regulatory compliance and risk management. Proven ability to lead cross-functional teams and optimize validation processes to ensure quality and adherence to industry standards.
Overview
15
15
years of professional experience
2008
2008
years of post-secondary education
Work History
Cleaning Validation Specialist
Torrent Pharmaceuticals Limited
Dahej
12.2021 - Current
- Conducted validation of manufacturing processes for pharmaceutical products.
- Reviewed and approved validation protocols and reports for compliance.
- Collaborated with cross-functional teams to ensure quality standards.
- Developed and maintained validation documentation for regulatory submissions.
- Trained staff on validation procedures and best practices in pharmaceuticals.
- Participated in audits to ensure adherence to industry regulations and guidelines.
- Assisted in troubleshooting and resolving validation-related issues during production.
- Documented results of all validation tests performed for future reference and audit purposes.
- Provided technical support in the installation, configuration and qualification of computer systems.
- Evaluated new technologies for potential use in system development projects.
- Developed test protocols, plans, scripts and reports for system validation activities.
- Conducted functional, performance and usability tests on software applications to ensure quality assurance.
- Identified areas requiring improvement in current processes related to software validation.
- Assisted in developing strategies for validating new products, processes or services prior to launch.
- Ensured that all systems comply with applicable regulatory guidelines such as FDA 21 CFR Part 11.
Senior Executive, Quality Assurance
Alembic Pharmaceuticals
09.2018 - 12.2021
- Handling below mentioned activities with team managemen
- Preparation of cleaning validation protocol, execution of cleaning validation and preparation of summary report.
- Preparation of process validation protocol, execution of process validation and preparation of summary report.
- Optimization of ANDA Batches (Stability, Process Characterization and Process Validation), review of batch manufacturing record and batch packing record.
- Execution and Monitoring of IQ, OQ & PQ protocols of all the equipments which are utilized in manufacturing.
- Internal Quality Observations and Compliance.
- Reviewing of Master BMR, BPR, Stability, Process Characterization, Process validation and Hold time studies Protocol and Reports along with Risk Assessment.
- In process sampling in Stability, Process Characterization and Process Validation of Sex hormonal gels, General topical, immune suppressants and corticosteroid drugs and their formulation.
- In process sampling in manufacturing and packing in Stability, Process Characterization and Process Validation of various dosage forms like Solid Oral dosage forms along with topical dosage forms like Ointment, gels, shampoo, topical solutions, lotions, creams, sprays, foams in various types of packs like tube (Aluminum and laminated), Bottles, sprays, pumps, sachets etc.
- Overview of Handling of Incident/Events and investigation.
- Handling of Change controls and evaluation of the changes in accordance to regulatory guidelines.
- Area, equipment Clearance in Dispensing, Manufacturing and Packing area.
- Review and approval of Art work (Carton, labels, pack insert, Printed labels, foils)
- Handled regulatory Audits of USFDA, MHRA, ANVISA and other customer audits
- Review of Computer System Validation protocols and its execution.
Executive, Quality Assurance
Sun Pharmaceuticals Limited
05.2012 - 09.2018
- Preparation of cleaning validation protocol, execution of cleaning validation and preparation of summary report.
- Preparation of process validation protocol, execution of process validation and preparation of summary report.
- Optimization of ANDA Batches (Stability, Process Characterization and Process Validation), review of batch manufacturing record and batch packing record.
- Execution and Monitoring of IQ, OQ & PQ protocols of all the equipments which are utilized in manufacturing.
- Internal Quality Observations and Compliance.
- Reviewing of Master BMR, BPR, Stability, Process Characterization, Process validation and Hold time studies.
- Protocol and Reports along with Risk Assessment.
- In process sampling in Stability, Process Characterization and Process Validation of Sex Hormone Products having very potent doses.
- In process sampling in manufacturing and packing in Stability, Process Characterization and Process Validation of various Sex Hormone Soft Gelatin products, gels and creams.
- Overview of Handling of Incident/Events and investigation.
- Handling of Change controls and evaluation of the changes in accordance to regulatory guidelines.
- Area, equipment Clearance in Dispensing, Manufacturing and Packing area.
- Inspection and Checking Of Art work (Carton, Foil, Leaflets, Labels)
- Handled regulatory Audits of USFDA, MHRA, ANVISA,
- Containment Study of Sex Hormone Area.
- Review of Computer System Validation protocols and its execution.
Officer, Quality Assurance
Osaka Pharmaceuticals Limited
06.2010 - 04.2012
- Verification while Dispensing of Raw materials and Active pharmaceutical ingredients.
- Preparation, issuance and Checking of Master Batch Manufacturing Record and Batch Packing Record.
- Knowledge of all in-process Quality Control Tests of Tablets, Capsules, Dry Powder, Suspensions, Syrups.
- Knowledge of SOP creation, Master documentation creation and Batch manufacturing & batch Packaging Records creation.
- Handled Process Validation, Cleaning Validation.
- Inspection and Checking Of Art work (Carton, Foil, Leaflets, Labels.
- Handled regulatory Audits of Glenmark, Colorama (UK), Cipla, Sarabhai, and Johnson & Johnson, Wockhardt, Ranbaxy.
- Handled regulatory Audits of WHO guidelines & USFDA
- Handling of Stability Study of Various products & their documentation
Education
M.Pharmacy - Medicinal Chemistry
M.S University
Vadodara 06.2008 - 2010
B.Pharmacy -
NET Pharmacy College, Raichur
Rajiv 09.2003 - 03.2008
Vidhyut Board Vidyalaya
VADODARA10th -
Sri C.R. Patel Vidyalaya, GSEB
VadodaraSkills
- Train the trainer
- Internal Auditor
- Technical Skills like Team management, Leadership, Problem Solving
- Trackwise
- LIMS
- ERP
- LMS, FMS, Minitab
- Microsoft Office Suite (Word, Excel,PowerPoint)
- Regulatory Affairs
- International Regulations
- Data Verification
- Risk Management
- CLEEN Software
- Validation documentation
- Validation protocols
- GMP auditing
- Software validation
- Quality management systems
- ISO standards
- Validation master plans
- Process validation
- Regulatory compliance
- Audit preparation
- Change control management
- Problem solving
- Effective communication
- Staff training
- Troubleshooting issues
Skills
- Technical Documentation
- Regulatory Documents
- Regulatory Policies
- Batch Records
Languages
English
Upper Intermediate
B2
Gujarati
Proficient
C2
Hindi
Proficient
C2
Timeline
Cleaning Validation Specialist
Torrent Pharmaceuticals Limited
12.2021 - Current
Senior Executive, Quality Assurance
Alembic Pharmaceuticals
09.2018 - 12.2021
Executive, Quality Assurance
Sun Pharmaceuticals Limited
05.2012 - 09.2018
Officer, Quality Assurance
Osaka Pharmaceuticals Limited
06.2010 - 04.2012
M.Pharmacy - Medicinal Chemistry
M.S University
06.2008 - 2010
B.Pharmacy -
NET Pharmacy College, Raichur
09.2003 - 03.2008
Vidhyut Board Vidyalaya
10th -
Sri C.R. Patel Vidyalaya, GSEB