Summary
Overview
Work History
Education
Skills
Projects handled
AWARDS AND HONORS
Certification
Websites
Work Availability
Quote
Timeline
Generic
MANIKANDAN P

MANIKANDAN P

CHENNAI

Summary

Energetic and enthusiastic quality & regulatory professional possess 06+ years of rich professional experience in manufacturing, QMS, training, regulatory and complaint handling from renowned pharmaceutical and medical device industries. Adds value to any organization in need of great collaboration, interpersonal and multitasking abilities. Meets tight deadlines. Adept at working effectively unsupervised and quickly mastering new skills. Believes in “putting patients first” in every deliverable, thus ensuring the delivery of quality products to patients.

Overview

7
7
years of professional experience
1
1
Certification

Work History

MDR Vigilance Specialist

Medtronic
Hyderabad
07.2021 - Current
  • Independently supported complaint receipt, analysis and investigation, IMDRF codes assignment, complaint closure, Adverse Event review and submission to regulatory authorities such as USFDA (Med Watch 3500A) EU (MIR), Health Canada etc..,
  • Supported as a CAPA owner and investigation for late regulatory AE reports and implementation of appropriate action plans and effectiveness checks which led to increase in the regulatory reporting Timeliness percentage to >99.7 from 84.
  • Implementation of ISO 14971 standards for Risk identification and mitigation strategies as per PMS(Post Market Surveillance) report and assisted in incorporating required design changes
  • Coordinated and supported in MDSAP audits review of SOP's, change management and associated GXP documents to ensure that it is as per the standards .
  • Supported for assurance of all requirements for the DHF Design Control and Verification of Documents of medical devices as per FDA 21 CFR part 820.30- Design control method
  • Reviewed and edited Quality Management System policies and procedures along with its related formats for clarity, accuracy, and compliance with EU regulations as well as ISO 13485:2016 standard.
  • Trained and mentored team in handling critical complaints, complaint closure strategies, effective communication, regulatory inquiries and robust customer response letters.
  • Executed many continuous improvement projects and quality initiatives adhering to the company's quality mission of "Putting Patient's first"

Senior Quality Engineer

L&T Technology Services (Client J&J)
Karnataka
03.2020 - 07.2021
  • Monitored the quality system for 400 suppliers of various domains from chemicals, packaging materials, excipient, fiber and non-woven grade materials from different regions APAC, EMEA, NA and LATAM.
  • Supported in ASL (Approved Supplier List) management, execution of various types of remote audits i.e.,Desktop audit, Quality questionnaire and Internal Assessment and data management in Track wise
  • Executed supplier quality performance review, Risk assessment, evaluation and mitigation for various supplier profiles based on their surveillance audit, NC's (non-conformances) and performance data
  • Supported in new product development and product quality improvement by qualification, monitoring and disengagement of suppliers.
  • Involved in supplier quality improvement by supplier training, review of their internal standards and procedures, execution of for-cause audits and GEMBA walks.

Associate-QA

Strides Arcolab Pvt.Ltd
Bengaluru
09.2019 - 03.2020
  • Supported in administration of Learning Management System (LMS) Compliance Wire and site training compliance management.
  • Involved in preparation of training materials for NC's and CAPA resulting from internal and external audit observations and assisted in Data Management for training related activities, deviations and product complaints.
  • Executed supplier Quality Questionnaire (QQ) audits, audit report preparation, sharing of observations and assisted supplier in supplier CAPA and corresponding follow-up audits.
  • Monitored QA procedures for adherence by employees, notifying personnel of non-compliance issues.
  • Analyzed quality assurance data to identify trends and develop and implement corrective action plans.
  • Executed cross functional internal audits and collaborated with management to discuss effective plans for resolving major quality problems.

Quality Assurance Officer

Sun Pharmaceutical Industries LTD
Kanchipuram
12.2018 - 08.2019
  • Handled QMS documents preparation, issuance, verification, retrieving and archiving this maintaining the flow of document life cycle in electronic document management system.
  • Supported Anytime audit readiness state by adhering to GMP standards and continuous training of shop floor persons in GDP by following error-free documenting of QMS documents.
  • Executed Sampling of RM, Intermediates and FP as per Standard Operating Procedures (SOP) and supported in management of control (stability) samples.
  • Maintained up-to-date knowledge of company and federal regulations to drive product quality, consistency and compliance.
  • Identified problematic areas deviated from quality standards and recommended corrective actions.

Jr.Quality Officer

Malladi Drugs And Pharmaceuticals Ltd
Andhra Pradesh
07.2016 - 12.2018
  • Supported in preparation, revise and review of SOP's, protocols and reports according to WHO GMP and USFDA standards.
  • Executed method validation and performance of Bacterial Endotoxin Test (BET) by Gel clot method and inoculum preparation activities for the manufacture of Phenyl Acetyl Carbinol (PAC).
  • Assisted in sampling,chemical and microbiological analysis of water and Raw Materials used for production as per STP (Standard test Protocols).
  • Drafted investigation and incident reports and submitted to appropriate personnel.
  • Ensured good safety practice and personal hygiene inside the industry according to industry standards.
  • Responded quickly to dispatch and took appropriate action at crime and disaster scenes.

Education

B.Tech - Biotechnology

Anna University
Chennai
04.2016

Skills

  • QMS: Track wise, MAP agile PLM, Veeva RIMS, SAP
  • LMS: Compliance Wire and Cornerstone
  • Minitab, Tableau, Power BI, MS office, Sharepoint
  • ISO 9001, ISO 13485, ISO 14971
  • PFMEA, PPAP and NPD(New Product Development)
  • DHF remediation & MDSAP audit support
  • IQ, OQ and PQ for equipments
  • PSUR, CER and PMS reports
  • IEC 62304, SDLC and V&V(Verification and Validation)
  • GxP audits, WHO, EUGMP, ICH and USFDA guidelines
  • Lean six sigma methodologies
  • Critical Thinking and problem solving
  • Training & Development
  • Team Management & Conflict Resolution

Projects handled

  

  • Led a team of 03 members and successfully completed the WIP (Work In Progress) closure project which resulted in the improvement of OCT (Open Complaint Timeliness) metrics for the team.
  • Supported and provided quality insights for Veeva Vault RIMS LCM (Life Cycle Management) software deployment to the site quality system.
  • Assisted 05-member team for a critical new supplier qualification audit during Covid crisis, resulted in an estimated potential savings of 200USD for the client

AWARDS AND HONORS

  • Awarded “Star of the Quarter” by Medtronic for exhibiting the Medtronic behavior of "Move with Speed and decisiveness".
  • Awarded "Best Performer" by Medtronic in MEIC Annual excellence Awards FY'22.
  • Awarded with “Star of the month” by L&T technology services for completing the project deliverables on time resulted in client’s appreciation.
  • Received client appreciation for the extraordinary support by gap identification in compliant records for MDSAP audit.

Certification

  • Certified Lean Six Sigma Green belt - TUV nord-Nov'23
  • Certified Fire Safety Professional-Medtronic-Mar'23
  • Certified Train the Trainer-Strides Pharma Sciences-Jan'20

Websites

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote

Whether you think you can or whether you think you can’t, you’re right!
Henry Ford

Timeline

MDR Vigilance Specialist

Medtronic
07.2021 - Current

Senior Quality Engineer

L&T Technology Services (Client J&J)
03.2020 - 07.2021

Associate-QA

Strides Arcolab Pvt.Ltd
09.2019 - 03.2020

Quality Assurance Officer

Sun Pharmaceutical Industries LTD
12.2018 - 08.2019

Jr.Quality Officer

Malladi Drugs And Pharmaceuticals Ltd
07.2016 - 12.2018

B.Tech - Biotechnology

Anna University

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