Saravanan K
Ramnadhapuram, Orivayal,TN
Summary
Dedicated Pharmaceutical professional with 15+Years Experience in Quality control Dept. History of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.
Overview
16
16
years of professional experience
Work History
Assistant Manager
Novitium Labs Pvt. Ltd
01.2023 - Current
- Having experience in injectables oral solid dosages, liquid orals, antibiotics.
- Coordination with auditors/visitors during regulatory/customer audits to explain the systems and procedures in the Quality control department.
- Carry out daily work plan, review of analytical reports and maintaining good laboratory practices.
- Expertise in Contamination Control & Risk Management: Implemented robust contamination control measures and risk management protocols, ensuring compliance with cGMP and enhancing quality of analysis .
- Comprehensive Regulatory and Quality Compliance: Deep knowledge of regulatory compliance and quality management systems, ensuring all Quality Control system align with industry standards and best practices
- Extensive expertise in US FDA, WHO, MHRA, inspections, data
- integrity (ALCOA+), stability lifecycle management, and QC governance. Proven ability to lead QC operations, manage critical OOS/OOT/CAPA investigations, and maintain sustained audit readiness.
- Experienced in building and mentoring QC teams, governing electronic data compliance, and partnering with QA, Manufacturing, and Regulatory Affairs to ensure patient safety and regulatory compliance
Senior Analyst
Endo Par Formulation Pvt. Ltd
07.2020 - 12.2022
- Approval and review of Reports in Quality control Document
Assistant Manager
Swiss Garnier Pvt. Ltd
07.2019 - 06.2020
- Head of the Quality control department .
- Responsible to ensure all the system and procedures are followed as per regulatory requirements.
- Preparation and review of SOPs, specifications and protocols and Cleaning validation & Stability protocol.
- Carry out daily work plan, review of analytical reports and maintaining and good laboratory practices.
- Preparation of calibration schedule & AMC of Instruments for QC and Quality control department.
- Daily verification of registers, log books and updating the training records.
- Coordination with auditors/visitors during regulatory/customer audits to explain the systems and procedures in the Quality control department.
Analyst
Par Formulation Private Ltd
12.2014 - 06.2019
- Performing Analysis for the finished products, stability products and raw material Samples.
- Performing Analytical Method Transfer, Cleaning& process validation and Hold Time Studies.
Research Officer
ACTAVIS Pharma
10.2013 - 12.2014
- Analysis of in-process samples. finished samples and using HPLC and GC with online documentation and analytical test report completion.
- Calibration of all Instruments and Equipments ( like HPLC, GC, Dissolution tester, Auotitrator, Disintegration, Friability).
- Maintaining the Calibration calendar of the above instruments and their Preventive Maintenance Chart.
- Making stability summary datasheet & Update summary report in system.
Chemist
Soft gel Health Care Pvt. Ltd
06.2012 - 09.2013
- Analysis of in-process samples. finished samples and using HPLC and GC with online documentation and analytical test report completion.
Junior Executive
Apex Laboratories
10.2009 - 05.2012
- Raw material sampling and wet lab analysis
Ensured GLP and GMP compliance across QC activities
Education
Master of Pharmacy - Pharmaceutical Chemistry
Dr. M.G.R. Medical University
IndiaSkills
- Instruments and Software’s Knowledge:
- HPLC: Waters, Agilent and Shimadzu with Empower 3, Chromeleon, Chemstation & LC Solution software’s
- UPLC: Waters and Shimadzu
- Dissolution: Electro lab, Dis Teck and Varian
- UV: Shimadzu
- FT- IR: Shimadzu
- GC: Agilent with Empower 3 Software
- KF Titration: Metrohm
- MS-Office
LANGUAGES
English
Tamil
Hindi
Intermediate (B1)
DECLARATION
I do hereby confirm that the information furnished above is true to the best of my knowledge and belief.
Place: Chennai
Your Sincerely
Saravanan K
Timeline
Assistant Manager
Novitium Labs Pvt. Ltd
01.2023 - Current
Senior Analyst
Endo Par Formulation Pvt. Ltd
07.2020 - 12.2022
Assistant Manager
Swiss Garnier Pvt. Ltd
07.2019 - 06.2020
Analyst
Par Formulation Private Ltd
12.2014 - 06.2019
Research Officer
ACTAVIS Pharma
10.2013 - 12.2014
Chemist
Soft gel Health Care Pvt. Ltd
06.2012 - 09.2013
Junior Executive
Apex Laboratories
10.2009 - 05.2012
Master of Pharmacy - Pharmaceutical Chemistry
Dr. M.G.R. Medical University