Process XE- EBMR, EBPR
Riyaz Gohil
Pharmaceutical Manufacturing
Bharuch
Summary
Looking for a challenging position of responsibilities that would allow me to utilize my education and professional experience in an organization where I would be deserved for my further growing and learning process.
Overview
9
9
years of professional experience
3
3
Languages
Work History
Production Senior Executive
Unique Pharmaceutical Laboratories (A Division of J. B. Chemicals and Pharmaceuticals Ltd.)
06.2020 - Current
- Planned and executed monthly production in alignment with validated capacities, regulatory commitments, and cGMP requirements.
- Ensured strict adherence to approved SOPs, BMRs, and validated processes with complete and compliant documentation practices.
- Verified equipment readiness (cleaning, calibration, PM, validation) prior to use to ensure full compliance and audit readiness.
- Managed manpower planning, ensuring only trained and authorized personnel performed GMP-critical operations.
- Converted production plans into SAP process orders with full traceability and system-document alignment.
- Led deviation handling, change controls, RCA investigations, and effective CAPA implementation.
- Maintained inspection readiness through continuous risk assessment and compliance monitoring.
- Prepared and revised SOPs; ensured timely GMP training execution as per the training management system.
- Oversaw water system monitoring and validated operational controls.
- Supported audits and regulatory inspections with accurate documentation and operational justifications.
- Contributed to annual budgeting, expense forecasting, and spares management to ensure cost control and uninterrupted operations.
- Managed SAP procurement (PR creation & tracking) and coordinated with cross-functional teams.
- Prepared and analyzed MIS reports to monitor production performance and operational metrics.
- Participated in qualification of equipment and facility areas, and supported process validation activities to ensure regulatory compliance and operational readiness.
- Collaborated with cross-functional teams including Purchase and Supply Chain to achieve production commitments and ensure timely material availability.
- Improved productivity and product quality by conducting refresher training sessions for shop-floor personnel on critical GMP and operational topics.
- Contributed to Management Review Meetings related to new facility and equipment introduction, gap assessments, deviation investigations, and continuous improvement initiatives.
- Reviewed and approved validation protocols, SOPs, Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), and other QMS documents to ensure compliance and data integrity.
- Managed and monitored serialization systems to ensure regulatory compliance and accurate product traceability.
- Participated in Factory Acceptance Tests (FAT) for new equipment to verify compliance with URS and operational requirements.
- Supported investigations of machine breakdowns, identifying root causes and implementing corrective actions to prevent recurrence and minimize production downtime.
Production Senior Officer
Intas Pharmaceuticals Ltd.
06.2017 - 05.2020
- Supervised filtration, filling, and sealing operations in the Parenteral Department, ensuring compliance with GMP, approved procedures, and regulatory guidelines.
- Maintained strict control of aseptic areas, including line clearance, environmental monitoring, cleanliness, and adherence to aseptic practices.
- Ensured accurate and timely documentation of logbooks, equipment records, BMRs, and process parameters, maintaining audit readiness.
- Coordinated with Engineering, QA, and QC for smooth equipment operation, deviation handling, and uninterrupted manufacturing activities.
- Monitored production performance to achieve targeted output with optimum yield, minimal wastage, and consistent product quality.
- Identified and escalated deviations and process abnormalities; supported investigations, CAPA implementation, and continuous improvement initiatives.
Education
M. Pharm - Pharmaceutics
Parul university
01.2017
B. Pharm - undefined
North Maharashtra University
Jalgaon01.2015
Skills
Keen Learner with Positive Approach
Ability to establish and maintain good working relationships at all levels
Can work in organized way along with team
Software
Qedge TMS- Training Management System
Qedge QMS- Quality Management System
Caliber BRM- EBMR, EBPR
Caliber DMS- Document Management System
Timeline
Production Senior Executive
Unique Pharmaceutical Laboratories (A Division of J. B. Chemicals and Pharmaceuticals Ltd.)
06.2020 - Current
Production Senior Officer
Intas Pharmaceuticals Ltd.
06.2017 - 05.2020
B. Pharm - undefined
North Maharashtra University
M. Pharm - Pharmaceutics
Parul university
Areas Of Interest
Production
Addresses
- Permanent Address: Navi Vasahat, Mothiya, Bharuch, Gujarat, 393030.
- Current Address: B2/01 Gulshan E Faiz Residency, Oppo. Lords Plaza Hotel, Near Railway Station, Ankleshwar, Bharuch, Gujarat, 393001.
Personal Information
- Date of Birth: 04th August 1994
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Declaration
I assure you that I can be an effective team member and shall contribute to the success of my team, project and the organization. I hereby declare that the particulars furnished above are true to the best of my knowledge.
Riyaz Gohil