R. RAMAN
Hosur
Overview
28
28
years of professional experience
1
1
Language
Work History
Vice President - Corporate Quality
Geltec Private Limited - Mumbai
10.2021 - 08.2023
- Review and Approval of various documents
- Timely release of products
- Disposal of OOS and corrective actions
- Handling of market complaints
- Handling of change control and deviation
- Planning analysis and submission of stability data
- Review of working standard and calibration documents
- Prepared Geltec - Sarigam facility for USFDA Audit.
General Manager - Corporate Quality
Apex Laboratories Private Limited - Chennai
12.2016 - 09.2021
- Review and Approval of various documents
- Timely release of products
- Disposal of OOS and corrective actions
- Handling of market complaints
- Handling of change control and deviation
- Planning analysis and submission of stability data
- Review of working standard and calibration documents
- Faced audits like USFDA, MHRA, MCC, GCC, ANVISA.
Vice President - Corporate Quality
Exemed Pharmaceuticals - Gujarat
05.2015 - 12.2016
- Review and Approval of various documents
- Timely release of products
- Disposal of OOS and corrective actions
- Handling of market complaints
- Handling of change control and deviation
- Planning analysis and submission of stability data
- Review of working standard and calibration documents
- Faced EUGMP audit with zero observations.
Asst. General Manager - QA / QC
Wanbury Limited Patalganga
05.2014 - 05.2015
- Review and Approval of various documents
- Timely release of products
- Disposal of OOS and corrective actions
- Handling of market complaints
- Handling of change control and deviation
- Planning analysis and submission of stability data
- Review of working standard and calibration documents.
Senior Manager
GLOBAL CALCIUM Pvt Ltd.
06.2011 - 04.2014
- Review and Approval of various documents
- Timely release of products
- Disposal of OOS and corrective actions
- Handling of market complaints
- Planning analysis and submission of stability data
- Trainings.
Senior Executive
ORCHID HEALTH CARE
02.2003 - 06.2011
- Performing self-inspection across the facility
- Shift management
- Raw Material preparation and monitoring
- Stability studies
- Compliance activities
- Trainings.
Senior Analytical Chemist
AMERICAN REMEDIES LTD.
01.1998 - 02.2003
- Testing and Releasing of Raw material, In-process, Intermediates, and Finished products.
Chemist
RESONANCE LABS
06.1995 - 01.1998
- Sampling, Testing and Releasing of Raw material, In-process, Intermediates, and Finished products by wet and Instrumental method.
Skills
Under my leadership during the month of January 2019 we faced EUGMP audit in Apex Laboratories Private Limited, cleared the audit and received EUGMP Certificate
Under my leadership apex facility has been prepared to face USFDA and UKMHRA Audit
Under my leadership during the month of June 2016 faced EUGMP audit in Exemed Pharmaceuticals and cleared the audit with zero observation Received EUGMP Certificate as well
Exemed Pharmaceuticals Productivity increased by 2 times after I joined and made changes in Process, systems and procedures in Exemed Pharmaceuticals
Prior to my joining, Exemed Pharmaceuticals faced problem in Quality of product and every year raised minimum 20 OOS and 25 OOT I identified the root cause and implemented effective CAPA This year Exemed Pharmaceuticals has only 2 OOS and no OOT
I have implemented systems and procedures for cGMP, Good documentation practices, Good Laboratory Practices in Orchid Healthcare, Global Calcium Private Limited, Wanbury Limited , Exemed Pharmaceuticals, Apex Laboratories Private Limited and Geltec Private Limited
During the Month of June 6th to 9th directly faced EUGMP audit and cleared with Zero observations
Faced audits like USFDA, MHRA, MCC, GCC, Agência Nacional deVigilância Sanitária (Health Surveillance National Agency) Brazil ANVISA
Excellent Planner to test and release RM / PM / IP / FP / STB batches in timely manner
Excellent knowledge on Planning and preparation of facility and documents for facing Regulatory Audits
Excellent knowledge on identifying root cause, risk assessment during non-conformance / deviations and implement effective CAPA for such non-conformance
Excellent knowledge on review of investigation documents
Excellent knowledge in Self inspection
Commitment to the work for the completion of the work with in the stipulated time
Excellent team management with the team members for the completion of targets with in the stipulated time
Knowledge of Trouble shooting for various process equipment / analytical Instruments
Knowledge of Trouble shooting for various process techniques / analytical Techniques
Participate as an active member in Compliance programme
Areas Of Exposure
Quality Assurance / Quality Control: Directing, controlling and staffing Quality department to ensure support for the execution of Quality Systems. Handling of QMS documents. Handling of VMP / SMF. Approving SOPs. Continually reviewing the requirements related to cGxP and changes in technology, facilities, customer focus. Approving specifications, standard testing procedures and other documentation; ensuring adherence to the GLP compliance.
Analytical Development: Managing development of analytical methods and its validation for various regulatory bodies Drug Master File submission purpose as per ICH & EMA guidelines. Planning to perform method suitability for USP & Ph.Eur monograph methods and variation notification to respective pharmacopeias.
Academic Credentials
Master of Science Chemistry from Madurai Kamaraj University
Accountability
- Vice President – Corporate Quality, Exemed Pharmaceuticals, Preparing the sites for Audits (Regulatory / customer), Conduct Quality Review Meeting, Conducting Internal Audits, Review and Approval of APQR, Review and approval of Monthly PQR, Review of OOS documents, Review of Market complaints, Review of Change control, Review of deviation, Review of Training documents, Review and Approval of Cleaning validation Protocol and Report, Review and Approval of Process validation Protocol and Report, Review and Approval of Water System Qualification Protocol and Report, Review and Approval of HVAC System Validation Protocol and Report, Review and Approval of Analytical Method Validation and Report, Review and Approval of SOPs related to QA, QC, HR, Warehouse, Production etc., Review and Approval of SMF and VMP, Review and Approval of Master schedule for Calibration, Performance verification and Preventive maintenance for Equipment and Instruments
- Asst. General Manager QA & QC, Wanbury Limited, Review and Approval APQR, Review and Approval of Cleaning validation Protocol and Report, Review and Approval of Process validation Protocol and Report, Review and Approval of SOPs related to QA, QC, Warehouse, Production etc., Review and Approval of Specification and Standard Testing Procedure, Review and Approval of SMF and MVP, Review and Approval of Master schedule for Calibration, Performance verification and Preventive maintenance for Equipments and Instruments, Timely release of raw material, intermediate and final products without any deviation, Disposal of OOS and Corrective action with in stipulated time, Handling of Market complaints, Handling of change control and deviation, Planning analysis, Review and submission of stability data to Regulatory, Review of working standard and calibration documents, Review of STP’s and SOP’s, On-Job Training for newly joined chemist, Handling of Reference standard, Co-ordination with R & D to resolve analytical issues, Enhancement of chemist productivity by regular monitoring and interaction, Timely analysis, Review and report preparation of process and cleaning validation Samples, Budget monitoring and control on procurement of chemicals, solvents, instruments, Spares and HPLC/GC columns, Reviewing of stability and holding time study data
- Head QA & QC, Global Calcium, Review and Approval APQR, Review and Approval of Cleaning validation Protocol and Report, Review and Approval of Process validation Protocol and Report, Review and Approval of SOPs related to QA, QC, Warehouse, Production etc., Review and Approval of Specification and Standard Testing Procedure, Review and Approval of SMF and MVP, Review and Approval of Master schedule for Calibration, Performance verification and Preventive maintenance for Equipments and Instruments, Timely release of raw material, intermediate and final products without any deviation, Disposal of OOS and Corrective action with in stipulated time, Handling of Market complaints, Handling of change control and deviation, Planning analysis, Review and submission of stability data to Regulatory, Review of working standard and calibration documents, Review of STP’s and SOP’s, On-Job Training for newly joined chemist, Handling of Reference standard, Co-ordination with R & D to resolve analytical issues, Enhancement of chemist productivity by regular monitoring and interaction, Timely analysis, Review and report preparation of process and cleaning validation Samples, Budget monitoring and control on procurement of chemicals, solvents, instruments, Spares and HPLC/GC columns, Reviewing of stability and holding time study data
- Audit and Compliance Incharge, Orchid, Performing self-inspection across the facility, Shift management, Raw Material, Stability, Compliance, Working and reference standards, Trainings
- Senior Analytical Chemist, American Remedies Ltd., Testing and Releasing of Raw material, In-process, Intermediates, and Finished products
- Chemist, Resonance Labs, Sampling, Testing and Releasing of Raw material, In-process, Intermediates, and Finished products by wet and Instrumental method
Instruments Knowledge
- High Performance Liquid chromatography-Waters, Agilent and Shimadzu
- Gas chromatography with Head space and manual injector-Shimadzu, Agilent, Perkin Elmer and Varian
- Differential Scanning calorimetry-Mettler Toledo
- FTIR - Shimadzu, Perkin Elmer
- UV-Spectrophotometer-Shimadzu, Carry-Varian, Agilent
- Auto Titrators- Mettler Toledo, Metrohm and Orion
- Particle size analyzer-Malvern
- Karl Fischer Titrators-Mettler Toledo, Metrohm
- Atomic Absorption spectra
- Ion chromatography- Metrohm
Regulatory Support
Maintaining the total documentation related to submission of ANDA. Handling of the customer complaints in coordination with QA & RA. Timely support to the regulatory activities in view of specs and Test Methods, stability data submission for ANDA filings.
Father's Name
M. RATHINAM
Mailing Address
Flat No. 73, Anand Nagar, Phase I Extension, Bhavani Street, Hosur, Tamil Nadu, 635126
Career Overview
A seasoned professional with over 28 + years of rich experience in Audit and Compliance, Audit Support, Gap Analysis, Qualification, Validation, Training, Pharma Projects, Quality Assurance, Quality Control, Analytical Development and Team Management. Presently Started own Consultancy to provide my Expertise in Quality Assurance, Quality Control management and audit handling for various regulatory bodies like USFDA, EDQM, MHRA, EUGMP, TGA, ANVISA, NAFDAC, UKRAINE and MCC. Expertise in streamlining processes/ procedures to facilitate robust quality systems at plant & during development. Adept in designing quality systems and implementing quality processes that will enable organization to consistently meet and enhance high quality output. Expertise in identifying Data Integrity issues, Gap analysis, Investigation, Risk Assessment, Internal Audit, QMS, Validations, Qualifications, Method Development, lab practices, part 11 compliance and documentation. Possess strong skills in Technology transfer, quality design for new products & validation of manufacturing process and analytical methods. Excellent in investigation analytical, troubleshooting and inter-personal skills with proven ability in driving numerous quality enhancement, process improvement and cost savings initiatives.
Personal Information
- Date of Birth: 06/09/73
- Nationality: Indian
- Marital Status: Married
Timeline
Vice President - Corporate Quality
Geltec Private Limited - Mumbai
10.2021 - 08.2023
General Manager - Corporate Quality
Apex Laboratories Private Limited - Chennai
12.2016 - 09.2021
Vice President - Corporate Quality
Exemed Pharmaceuticals - Gujarat
05.2015 - 12.2016
Asst. General Manager - QA / QC
Wanbury Limited Patalganga
05.2014 - 05.2015
Senior Manager
GLOBAL CALCIUM Pvt Ltd.
06.2011 - 04.2014
Senior Executive
ORCHID HEALTH CARE
02.2003 - 06.2011
Senior Analytical Chemist
AMERICAN REMEDIES LTD.
01.1998 - 02.2003
Chemist
RESONANCE LABS
06.1995 - 01.1998