To pursue a challenging and accountable role that positively contributes to organizational growth through competitive, progressive, and innovative approaches—leveraging my skills and knowledge to add value to myself, the department, and the organization while continuing to grow professionally.
Overview
5
5
years of professional experience
Work History
RDCM Data and Conformance Manager (Sr. Associate-I)
Pfizer Health Care India Private Limited
Chennai
01.2023 - Current
Committed to quality and excellence in compliance and conformance
With the reasonable understanding of Regional Regulations, would perform the evaluation of the notifications assigned.
Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets.
Contributes independently and manages own time to meet the timelines.
Work in collaboration with GRA colleagues to ensure the gaps are identified and escalated on time.
Independently Perform accurate updates in system for most of the cases and consult with TL/Designee for clarification of any discrepancies in complex cases, before updating the system.
Makes informed decisions on straight cases within guidelines and policies.
Support for updates in system for License withdrawals.
Operate in line with internal SOPs and policies.
Escalate any potential compliance issues to management.
Support periodic and ad-hoc system reports to estimate metrics.
Assist in remediation activities.
Support for update in systems for Drug Product and Active Ingredient manufacturer details.
Research Executive
Pfizer Health Care India Private Limited
Chennai
01.2021 - 01.2023
Worked on the Analytical development for the following projects: Depot Injectable Suspension indicated for the treatment Schizophrenia.
Prefilled syringes Indicated for General anesthetics, treatment of Acidosis, improve breathing, stimulate the heart, and raise a dropping blood pressure.
Dry powder mixture for Injection (Dual chamber) indicated for the treatment stomach infections, skin infections and pneumonia.
Act-O-vial and Shark Prefilled syringes indicate nutritional deficiency.
Antidote indicates for the treatment of known or suspected cyanide poisoning.
Large Volume parenteral concentrate for Anti Biotics.
Analytical Method Development for drug products.
Perform the analysis of stability samples for parenteral products.
Involved in Innovator product characterization.
Execution of all pivotal studies like Material compatibility study, and diluent compatibility study for injectable on Analytical Front.
Actively involving project review meetings with core and extended team members (both local and global).
Performing routine activities pertaining to lab ensuring compliance to established procedures and safety.
Perform the routine analytical testing for pH, Assay and Related Substances.
Perform the Calibration of analytical instruments like analytical balance, pH meter.
Perform Good Documentation and Laboratory Practices as per GDP & GLP in Electronic Lab Note Book.
Education
M. Pharm - Pharmaceutical Chemistry
Madras Medical College
Chennai
01.2017
B-PHARMACY -
Aadhibhagawan college of Pharmacy
Thiruvannamalai
01.2014
Class XII -
Govt Higher Sec School
Kancheepuram
01.2010
Class X -
Govt High School
Thiruvannamali
01.2008
Skills
Decision-making when things aren't clear
Taking responsibility beyond assigned tasks
Comfort with changing priorities
Clear communication under pressure
Fast learning ability
Ability to operate independently in ambiguous situations
Creative and Ability to Adapt in Real-Time
Good communication skill
Awards And Publications
Received complementary award from Indian Pharmaceutical Association (Tamil Nadu Branch-Pith Trust)
Design and synthesis of some newer imidazole-yl Heterocycles as potent BTK inhibitors for the treatment of Rheumatoid Arthritis.
Virtual screening and pharmacological evaluation of newer BTK inhibitors as potent Anti-Rheumatoid Arthritic agents.
Dissertation Work
Design Synthesis and Pharmacological Evaluation of some Newer Imidazol-yl Heterocycles as a potent BTK Inhibitor for the Treatment of Rheumatoid Arthritis., Anti-Arthritic Activity of Methanolic Extract of Achyranthes Aspera Linn
Computing Skills
Veeva Vault rim
RIM Ennov Insight (PEARL)
Product Dossier Manager (PDM)
COMPASS SCC’s
GDMS & Track wise
Empower 3.0
Electronic Notebook
Microsoft Office & C Programme
In-Silico drug designing and docking (Glide, AutoDock, Argus)
Operation of Waters HPLC
Operation of UPLC with Empower 3 software
Operation of UV-Visible Spectrophotometer
Operation of infrared spectroscopy
Scientific data retrieval.
Workshops Conferences Trainings
Texo PharmaVirtus, Mother Theresa Institute of Technology, Pudhuchery, 11/01/12
Indian Pharmaceutical Congress, 2013
Indian Pharmaceutical Congress, 2015
ICMR national seminar, Mother Theresa Institute of Technology, Pudhuchery, 2013
AICTE Sponsored National Seminar, JKKMMRF’s Annai Sampoorni Ammal College of Pharmacy, Komarapalaym, Namakkal, Not specified
National Conference on Emerging trends industrial Pharmacognosy, Mother Theresa Institute of Technology, 04/01/14
CMC on PATANCY, TN Dr. M. G. R. Medical University, Chennai-32, 2016
Workshop on Drug Design, Madras Medical College, Chennai-03, 2016
Workshop on Gas Chromatography, Sri Ramachandra University, Chennai-116, 11/01/16
Basics & Operation Training on fundamentals and operational of LC-MS, Thermo Scientifics, Bengaluru, 08/01/19
Languages
English
Tamil
Hobbies and Interests
Reading Tamil stories
Playing Games
Farming and gardening
Personal Information
Total Experience: 8 Years 5 Months
Father's Name: C. Anandhan
Date of Birth: 12/31/90
Marital Status: Married
Disclaimer
I hereby declare that all the above-mentioned information furnished is true and correct to the best of my knowledge and belief.
Timeline
RDCM Data and Conformance Manager (Sr. Associate-I)
Regulatory Data and Conformance Manager Associate - II at Pfizer Healthcare India Private LimitedRegulatory Data and Conformance Manager Associate - II at Pfizer Healthcare India Private Limited
Sr. Associate – Managing Data Quality, Reference Data and Reporting at JP Morgan Chase & Co.Sr. Associate – Managing Data Quality, Reference Data and Reporting at JP Morgan Chase & Co.