Supriya Dwivedi
Auckland
Summary
Team-oriented critical thinker with loads of loads of experience in quality control and management across manufacturing and research areas. Motivated to join a group of seasoned business analysts and cross-functional teammates, where I anticipate growth and the chance to prove my abilities.
Compliance professional with demonstrated expertise in regulatory adherence and risk management. Adept at developing and implementing compliance programs that ensure alignment with industry standards. Known for strong focus on team collaboration and achieving results, with flexible approach to evolving needs. Skilled in policy development, auditing, and problem-solving, ensuring organizational integrity and trust.
Overview
10
10
years of professional experience
1
1
Certification
Work History
QUALITY AND COMPLIANCE SPECIALIST
10.2024 - Current
- Policies, Procedure & Information Management: Implementing and Maintaining Document Management Systems for All Process and Information.
- Primary Owner of SOP System
- Facilitating New Procedures, Documents and Updating Existing Documents as Required
- Managing Document Control System for The Site
- Develop Training Material as Required to Ensure the Site and Teams Have a Thorough Understanding of Requirements.
- Manage All Licenses and Certifications Required to Operate – CAA, TF, CCA – so that site always Complies.
- CAA Compliance:
- Act as a Senior Person for the Purposes of CAA Rule 109 and Compliance in this Space.
- Maintain Security Systems, Issuing and Controlling Security Passes.
- Audit Security Breaches, Lead and Ensure Close Out of Non-Conformances.
- Assist With the Known Customer Audits and Onboarding.
- Maintain Known Customer Register and Updates.
- Assist In the External CAA Audits, Review and Assist in Close of Non-Conformances.
- CCA and MPI Transitional Facility Compliance
- Working with teams on Non-Compliance Issues
- Manages all Internal Compliance Audits and works with external agencies to support them in external compliance audits.
- Fixed Term- Maternity Coverage
TEST ANALYST
KUSOL LABS
10.2022 - 03.2023
- Worked as automation tester in KUSOL LABS, New Zealand with below mentioned roles/responsibilities:
- Requirement Analysis
- Test Execution: Performed Functional, Exploratory, Regression, and Integration testing to validate the functionality and reliability of the software.
- Test Script Creation: Developed detailed test scripts for web applications, documenting precise testing procedures to maintain consistency in testing processes.
- Automation Support: Assisted in test automation by creating test scenarios using Selenium, contributing to increased testing efficiency and coverage.
- Issue Tracking: Collaborated closely with developers to identify, track, and resolve issues through internal testing, ensuring that defects were promptly addressed.
QUALITY OFFICER
Pictor Limited
06.2022 - 10.2022
- Worked as a Quality Officer in Pictor Limited, Parnell, Auckland with below-mentioned roles/responsibilities:
- Document Control and maintenance of the QMS system.
- Participate in QMS management review meetings; collate Management Review presentation and minute the meeting.
- Schedule and perform internal quality audits & External Audits.
- Review and approve validation documentation as assigned.
- Maintain all the logs (eg: NC, CAPAs internal Audits etc).
- Coordinate and complete all the NC’s, CAPA’s Internal Audits, CAPA reviews etc on time.
- Contribute to Quality Incident and investigations to evaluate product quality and GMP aspects.
- Contribute to the implementation of any updates of Quality Management System into Pictor’s Manufacturing facilities.
- Contribute to the implementation of frequent GMP training and refresher training sessions.
- To perform Quality Control sampling, testing for Incoming materials and finished products when required.
QUALITY CONTROLLER
Fisher & Paykel, Health Care Limited
03.2022 - 06.2022
- Worked as a Quality Controller in Fisher & Paykel, Health Care Limited, Auckland with below-mentioned roles/responsibilities:
- Perform the quality inspections using sampling methods on finished products as part of the manufacturing process.
- Ensuring products are within specification by interpreting relevant quality control records and charts.
- Identifying non-conforming process and/or products and initiating non-conformance reports
- Updating the ERP software (SAP) to perform daily routine and release of the product.
RESEARCH SCIENTIST
Division of Nutrition, Indian Council of Medical research, Government of India
07.2017 - 10.2021
- Worked as Research Scientist in, Division of Nutrition, Indian Council of Medical research, Government of India.
- Co-Investigator for ICMR Task Force study on Iodine Deficiency Disorders.
- Programmed officer for Multi-centric Intervention study on Hypertension.
- Monitoring of Laboratory work, procurement of chemicals, equipment’s, Inventory management etc.
- Renewal of Laboratory accreditation by NABL during my term as Quality Manager
QUALITY MANAGER
Indian Council of Medical research, New Delhi
09.2015 - 10.2021
- As a Quality Manager at Indian Council of Medical research, New Delhi
- Co-ordinated all the laboratory activities for renewal of accreditation for laboratory under ISO 15189:2012, CNRT (Centre for promotion of nutrition research and training with special focus on North-East, Tribal and Inaccessible population), Indian Council of Medical Research, New Delhi.
- In my term as a Quality Manager the Laboratory got accredited as per ISO: 15189-2012 twice for the four years which includes two external audit (On-site audit by Lead & Technical Assessors after every two years) and two Desktop Surveillance (Online audit once in a year).
Education
Doctor of Philosophy -
01.2018
Master of Science - Biotechnology
01.2012
Diploma - Computer Application
01.2010
Skills
- Manufacturing Processes
- Quality Management System
- Internal Quality Control
- Internal & External Audits
- Export /Import
- Document Control
Certification
- Automation Testing Selenium with Java
- Quality Assurance-
- ISO 13485-2016
- ISO 15189 -2012
- ISO 17025-2012
- ISO 9001
- Accredited Person-MPI
- CAA-109
PROFESSIONAL SUMMARY
- Experienced individual in Quality Assurance and Management across manufacturing (GMP), Laboratory areas (GLP). Results-driven QA Professional with a focus on improving logistic processes and quality standards. Expertise in identifying and resolving quality issues and ensuring compliance with relevant regulations (CAA, CCA & MPI). Proven ability to implement and maintain quality control processes, analyse data for continuous improvement, and improving operational efficiency.
- Having a Ph. D in biotechnology with a research background. Been responsible for the whole quality management system of an ISO certified research laboratory. Strong communicator, team player, and problem solver. Ready to contribute and grow in.
KEY COMPETENCIES
- Collaborative Team Player: Proficient in working within a team-oriented and collaborative environment, fostering synergy to achieve project goals.
- Efficient Coordinator: Demonstrated ability to coordinate and follow up on tasks, independently driving assignments to successful completion.
- Leadership: Experienced in planning, supervising, and delegating daily activities of the compliance and operations team.
- Documentation: Experienced in writing the Quality documents i.e. Standard Operating Procedures/Expositions, Quality Manual, Non-Conformances reports and other relevant quality documents.
Timeline
QUALITY AND COMPLIANCE SPECIALIST
10.2024 - Current
TEST ANALYST
KUSOL LABS
10.2022 - 03.2023
QUALITY OFFICER
Pictor Limited
06.2022 - 10.2022
QUALITY CONTROLLER
Fisher & Paykel, Health Care Limited
03.2022 - 06.2022
RESEARCH SCIENTIST
Division of Nutrition, Indian Council of Medical research, Government of India
07.2017 - 10.2021
QUALITY MANAGER
Indian Council of Medical research, New Delhi
09.2015 - 10.2021
Master of Science - Biotechnology
Diploma - Computer Application
Doctor of Philosophy -
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