SAP, DMS, LMS, QMS, Trackwise, Master Control
Raghuraman Gopal
GM (Operations)
Sungai Petani
Summary
25+ years of success in leading QA/QC (QMS), Validation & Release Programs for the Delivery of High-Quality Pharma Products in various Dosage Forms as per cGMP/ Regulatory Compliances, while working in state-of-the-art Plants in the Pharmaceutical Industry across India, Poland & Malaysia
Diligent Director/GM QA with solid background in managing daily operations and driving team performance. Successfully led various projects, ensuring seamless execution and improved operational efficiency. Demonstrated strategic planning and effective communication skills. Professional leader with comprehensive experience in driving operational excellence and strategic growth. Proven track record of fostering team collaboration and achieving impactful results in dynamic environments. Skilled in navigating complex challenges, optimizing processes, and cultivating positive workplace cultures. Known for adaptability, effective communication, and strong decision-making abilities. Professional managerial candidate with deep understanding of operational excellence and team leadership. Proven ability to drive growth and enhance productivity through strategic planning and effective resource management. Emphasizes collaboration and adaptability to meet organizational goals, showcasing excellent problem-solving and decision-making abilities.
Overview
1
1
Language
7
7
Certifications
31
31
years of professional experience
Work History
GM
SM Pharmaceuticals Sdn.BHD Malaysia
01.2025 - Current
- Responsible and Accountable for Production, QA and QC Operations of SM Pharmaceuticals. Performance-driven Frontrunner to envision QA goals own big picture strategy that generates positive QA deliverables. Managing and ensuring harmonization of all QA /QC activities on the shop floor, for timely and best-in-class product delivery. Participating in Strategic Review Meetings, reviewing all QA functions /SOPs for effectiveness and recommending corrective actions. Providing leadership for completing Equipment/ Instrument/ Utility Lifecycle including URS, Risk Analysis, and Qualification Steps like a review of FRS/DQ, FAT, IQ, OQ and PQ including part of CSV
- Strategic Planning, QA / QC Operations
- Contributing to attaining strategic organizational objectives through effective Change Management Planning and Execution. Ensuring optimum quality of products, across NPD, production, laboratory, storage, distribution, vendors and third-party contractors
- Improving accuracy and resolving all issues associated with VMP, DQ, QRA, FAT, SAT, and IOQ Documents by in-depth analysis and review
- Supporting efficient processing of all Turnover and Vendor Document Packages by performing review and approval
- Leading efforts for streamlining the Commissioning and Qualification Processes for Purified Water Systems, Cleanrooms, HVAC Systems, Compressed Air Systems, Warehouses, Building Management Systems (BMS) and Energy Management Systems (EMS)
- Regularly liaising with customers/clients based on acceptance criteria. Maximizing customer satisfaction levels through planning and rollout of IQ and OQ Protocols for direct impact systems in line with customer specifications
- Enabling the smooth Qualification of Direct Impact Systems of Medical Devices, with a structured approach
- Spearheading successful commissioning activities for IOQ based on ASTM E2500 / ISPE requirements
- Building a robust Quality/Compliance-Driven Culture via companywide adherence to ISO 9001 Standards
- Directing & executing R&D, Technology Transfer, Quality Systems Improvement Projects and Activities, to improve overall product quality
- Managing QMS-Investigation of Non-Conformances (OOS, OOT, Deviation, Analytical Incidences) and Critical Quality Issues (Product Recall, Counterfeits, Contamination Control, Stability Failures, etc.), participating in Investigation, Hypothesis Testing to identify the root cause
- Assisting in New Product Development, QA/QC and Release of Raw Materials, Bulk, In-Process, and Finished Products (Formulation)
AGM- Quality
Bafna Pharmaceuticals Ltd
01.2024 - 01.2025
- Implemented DMS, LMS and QMS through Digitalization project.
- MHRA audit Successfully completed with no critical observations and the unit is cleared for MHRA approval. Driven the team towards continuous improvement.
- Strategic Planning, QA / QC Operations
- Contributing to attaining strategic organizational objectives through effective Change Management Planning and Execution. Ensuring optimum quality of products, across NPD, production, laboratory, storage, distribution, vendors and third-party contractors
- Improving accuracy and resolving all issues associated with VMP, SIA, DQ, QRA, FAT, SAT, and IOQ Documents by in-depth analysis and review
- Supporting efficient processing of all Turnover and Vendor Document Packages by performing review and approval
- Leading efforts for streamlining the Commissioning and Qualification Processes for Purified Water Systems, Cleanrooms, HVAC Systems, Compressed Air Systems, Warehouses, Building Management Systems (BMS) and Energy Management Systems (EMS)
- Regularly liaising with customers/clients based on acceptance criteria. Maximizing customer satisfaction levels through planning and rollout of IQ and OQ Protocols for direct impact systems in line with customer specifications
- Enabling the smooth Qualification of Direct Impact Systems of Medical Devices, with a structured approach
- Regulatory Compliances / Audits / Risk Management / Supplier QA/QC
- Confirming that Site Quality Management is operating in adherence with cGMP, XP & Regulatory / ICH/MHRA/USFDA Compliances
- Playing a significant role in Risk Management, and ensuring necessary proactive measures have been taken to moderate and control the risk
- Facilitating various Regulatory / Internal & External Audits, communicating findings and ensuring compliance with audit observations
- Directing Vendor Qualification Activity, monitoring vendors/ suppliers’ performance against quality, cost and lead time norms. Recommending and maintaining smooth operations, housekeeping & adherence to EHS standards in plant area for a safe & clean store environment
- Validation / Certifications / Data Integrity / Contracts
- Monitoring that Pharmaceutical Products are certified, and that each production batch produced is in line with Global QA Standards
- Spearheading Data Integrity, effectively ensuring all activities are performed as per respective SOPs, regulatory requirements
- Reviewing Production Batch Records, approving Master Batch Records and other cGMP documents from CMOs / Contract Laboratories.
- Spearheading the development, implementation and maintenance of Validation Standards in line with Regulatory Requirements (Validation Master Plan, Policies, Procedures and Protocol / Reports) at all times, affecting Sterile Manufacturing
- Directing the timely Qualification, Calibration and Maintenance of Instrument, Equipment & Software used in QC Lab for optimum results
- Administering Reference Samples, ensuring proper storage and upkeep of reference samples, giving Approval for withdrawal of reference samples in case of OOS and complaint investigation, monitoring and mapping of temperature and humidity of sample room
- Team Leadership, Training, Cross-Functional Coordination
- Providing leadership and expertise to cross-functional team members. Optimizing skills of team members in terms of cGMP and GDP Calibration Testing through regular training and coaching. Developing the team’s abilities in GMP Concepts and Data Integrity
- Directing the complete Training Lifecycle from training plans/ calendar/ module creation, training execution, assessments and certifications, integrating e-learning, and live sessions, to make the training engaging and understanding for the target audience
- Building and maintaining collaborative relationships within all levels of the organization as well as with external stakeholders through coordinated systems of training and development, robust communication and resolution of performance bottlenecks
QA / QC Manager
Exyte Malaysia SDN BHD
01.2021 - 01.2023
- Responsible and accountability for Validation of Utilities such as Air Handling Units, Nitrogen, Purified water and Compressed Air. Responsible for GDP and data integrity in harmonization with Medical devices lifecycle during construction . Review ITP according to specification and also carry out VMP based on the customer requirements and comply as per the acceptance criteria.Participating in Strategic Review Meetings, reviewing all QA functions /SOPs for effectiveness and recommending corrective actions. Providing leadership for completing Equipment/ Instrument/Utility Lifecycle including URS, Risk Analysis, and Qualification Steps like a review of FRS/DQ, FAT, IQ, OQ and PQ including part of CSV
- Strategic Planning, QA / QC Operations
- Contributing to attaining strategic organizational objectives through effective Change Management Planning and Execution. Ensuring optimum quality of products, across NPD, production, laboratory, storage, distribution, vendors and third-party contractors
- Improving accuracy and resolving all issues associated with VMP, SIA, DQ, QRA, FAT, SAT, and IOQ Documents by in-depth analysis and review
- Supporting efficient processing of all Turnover and Vendor Document Packages by performing review and approval
- Leading efforts for streamlining the Commissioning and Qualification Processes for Purified Water Systems, Cleanrooms, HVAC Systems, Compressed Air Systems, Warehouses, Building Management Systems (BMS) and Energy Management Systems (EMS)
- Regularly liaising with customers/clients based on acceptance criteria. Maximizing customer satisfaction levels through planning and rollout of IQ and OQ Protocols for direct impact systems in line with customer specifications
- Enabling the smooth Qualification of Direct Impact Systems of Medical Devices, with a structured approach
- Spearheading successful commissioning activities for IOQ based on ASTM E2500 / ISPE requirements
- Building a robust Quality/Compliance-Driven Culture via companywide adherence to ISO 9001 Standards
- Directing & executing R&D, Technology Transfer, Quality Systems Improvement Projects and Activities, to improve overall product quality
- Managing QMS-Investigation of Non-Conformances (OOS, OOT, Deviation, Analytical Incidences) and Critical Quality Issues (Product Recall, Counterfeits, Contamination Control, Stability Failures, etc.), participating in Investigation, Hypothesis Testing to identify the root cause
- Assisting in New Product Development, QA/QC and Release of Raw Materials, Bulk, In-Process, and Finished Products (Formulation)
QA Manager / Head
SM Pharmaceuticals SDN BHD
01.2015 - 01.2021
- Conducted extensive review of various documentation entailing SOP’s, technical specifications, batch manufacturing records, validation protocols and reports, quality documents, and change-control procedures. Accomplished on-time completion of Regulatory Audits by verifying cGMP and Quality Management Systems in line with quality and regulatory expectations. Oversaw all QC activities, uncovering and rectifying potential errors
- Significant Highlights:
- Ensured fulfillment of various Quality Standards and monitoring of relevant documents through the integration of robust quality systems
- Effectively resolved complex Market Complaints/Issues by testing new raw, packing, and in-process materials as well as finished goods
- Significantly improved Risk Control and Mitigation by designing and implementing a Quality Risk Management System
- Recorded key milestones and achieved:
- O Reduction in Market Complaints from 25 % to 10% in 3 years by using Pareto and Gap Analysis
- O 5% cost efficiency through impactful quality initiatives, like revamping basic quality philosophies, creation and deployment of QMS
- O Decrease in rejection rate by 3% visual defects in Sterile Manufacturing and incidence of defects by 3% via training, team forums and actions
- Successfully completed Process Validation for all Tablets and Sterile Dosage Forms; developed QRM to reduce market complaints and enhanced QMS PQ for all the products completed in a year for continuous 4 years, against previous only 20% completed before audits
- Delivered impactful Training Sessions to Executives, Officers, Operators and Chemists on cGMP, Contamination Control and Gowning Practices including Live Simulation and Case Studies, for a better understanding
- Facilitated seamless Knowledge Transfer between Quality Control and Contract Manufacturers, for improved quality across products
- Served as an SME for all Internal and External Quality-related aspects, including SOPs and Regulatory Compliance with a focus on fit-for-purpose
- Managed the overall PQS for OSD, Sterile Facility, Creams, Solutions and Syrups Forms, ensuring maximum quality
QA Manager / Head
DFE Pharma India LLP
01.2012 - 01.2015
- Owned all Quality Compliance and Facilitation aspects for Internal/ External Audits. Provided cGMP Training to drive Top-Tier Quality Compliance Standards. Served as a Key Member of the Management Team, developed second-level leaders, promoted Production, QA, Engineering and Quality Systems and successfully launched New Products in liaison with key stakeholders. Benchmarked the DFE Pharma Cuddalore Quality System as the DFE Corporate Quality System for 5 Units across the Globe
Group Leader
QAD Strides Arcolab Polska, Poland/ CQA Strides Arcolab, India
01.2008 - 01.2012
- Handled the internal Train the Trainer Team for OSD and Sterile Manufacturing and identified the key 30 people second-level leaders across the organization. Successfully conducted cGMP Documentation Video as well as developed and implemented Group CQA SOPs and procedures across various SBUs of the organisation
Manager QA
Jubilant Organosys, India
01.2008 - 01.2008
- Expertise in supporting manufacturing of APIs and its intermediaries; reducing rejections and ensuring the quality of end pharma products – oral solids, oral liquids and semi-solids in all respects. Supported all Validation (Process, Cleaning) and Qualification activities at all sites, Analysed Quality Gaps and drove Continuous Process Improvement to maximising product quality
Manager GMP Training
Panacea Biotec Ltd.
01.2007 - 01.2008
- Devised a Training Module for the OSD Greenfield Plant, Training Modules for Operators and Executives on MHRA/ANVISA Compliances. Effectively imparted training on cGMP, Documentation, SPC, QMS and Validation
Growth Path: Joined as Statistical Officer Trainee and rose to Asst. Manager – New Product Development
Dr. Reddys Laboratories Ltd.
01.1996 - 01.2005
- Contributed as a Member of Cost Improvement Projects like Packaging Differentiation, Inventory Cost and GC (Gross Consumption for Product) Stabilization, Implementation, and Rollout of SAP - MM, QM and PPIC Modules across Formulation Units (ROW). Developed Training Modules on Analytical Method Validation, Validation Concepts, and cGMP. Recognised as a Statistician who has developed and implemented Batch Records
Education
MBA - PGDHRM
Indira Gandhi National Open University
New Delhi, India 04.2001 -
B.Sc. - Statistics
St. Joseph’s College
Trichy, India01.1994
Skills
Strategic Planning & Execution
Manufacturing Operations Excellence
Greenfield Project Management
Supplier / Vendor Management
Risk Assessment & Mitigation
Packaging Innovation
Quality Management System (QMS)
New Set-Ups/R&D/Technology Transfer
Process Improvement/ Automation (SAP)
OOS/ Deviation/ Change Control
Quality Documents, Policies & SOPs
Quality Cross-Functional Coordination
Leadership and team building
Operations management
Problem resolution
Effective leader
Accomplishments
- Spearheaded and delivered a Greenfield Project of Medical Devices across the largest plant in Southeast Asia, supporting continuous Glucose Manufacturing at Exyte Malaysia SDN BHD
- Led & completed the IOQ (Installation and Operational Qualification) for the Utilities – Purified Water, Compressed Air, HVAC (AHU), Nitrogen & Argon at Exyte Malaysia SDN BHD
- Executed a Six Sigma Project for NPD from business development, tech transfer to product fitting to ROW/contract manufacturing/Loan licensing in a TAT of 305 days
- Received Appreciation from NPRA for building the Quality Culture and developing the second-level leaders, while ensuring documentation traceability and availability within 6 minutes.
- Successfully passed the ISO 9000, ISO 14001 Audits, all Customer Audits and Third-Party Audit by Rephine without any major issues continuously for 3 years at DFE Pharma India LLP
- Won Best Safety and Productivity Award, Best Team Award for SHE and QMS for DFE Pharma Cuddalore Plant in 2014
- Selected to impart SPC Training to NIPER for the WHO Capability Building Project, at all levels from Chemist to Top Management for government bodies.. Conducted 5 Seminars and received Appreciation for the same at Panacea Biotec Ltd.
- Implemented the CQA System in Strides Arcolab Polska that set the stage to get product approvals fast in EU and FDA
- Achieved Appreciation Letter from Management for getting MCA and other Regulatory Approvals at Dr. Reddys Laboratories
- Received the Best Team Award for Packaging Differentiation and Innovation at Dr. Reddys Laboratories
- Contributed as a Member of the Editorial Team in Dr. Reddys and DFE Pharma for the Internal Magazine and wrote various Articles on Quality
- Participated and facilitated the Bioinformatics Strategic Meeting held in Singapore in 2016 on Data Management – Conducted by Proventa International at Singapore.
Affiliations
C
Software
Certification
1995-CCQA from School of Quality Management
Interests
Reading books, Summary of Insights of the latest tools and technologies in Pharma
Timeline
GM
SM Pharmaceuticals Sdn.BHD Malaysia
01.2025 - Current
AGM- Quality
Bafna Pharmaceuticals Ltd
01.2024 - 01.2025
QA / QC Manager
Exyte Malaysia SDN BHD
01.2021 - 01.2023
QA Manager / Head
SM Pharmaceuticals SDN BHD
01.2015 - 01.2021
QA Manager / Head
DFE Pharma India LLP
01.2012 - 01.2015
Group Leader
QAD Strides Arcolab Polska, Poland/ CQA Strides Arcolab, India
01.2008 - 01.2012
Manager QA
Jubilant Organosys, India
01.2008 - 01.2008
Manager GMP Training
Panacea Biotec Ltd.
01.2007 - 01.2008
MBA - PGDHRM
Indira Gandhi National Open University
04.2001 -
Growth Path: Joined as Statistical Officer Trainee and rose to Asst. Manager – New Product Development
Dr. Reddys Laboratories Ltd.
01.1996 - 01.2005
B.Sc. - Statistics
St. Joseph’s College