Pari Subash
GMP Consultant for Pharmaceutical and other indust
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About
My name is Dr. Pari Subash, and I am writing to express my keen interest in exploring potential job opportunities in your esteemed organization. With over 25 years of exemplary experience in renowned MNC pharmaceuticals, I have garnered extensive expertise in various domains, including Solid Dosage, Sterile Power and Injectables, and API, particularly in QA/QC/MICRO/AR&D.
The success of my endeavors is evidenced by successfully navigating multiple regulatory audits, including USFDA (6 times), MHRA (4), EU-GMP (3), WHO (3), MCC (3), IDMA, INVIMA, ANVISA, PICS, TGA, Health Canada, and Cofepris.
A key aspect of my expertise lies in Computer System Validation (CSV) in accordance with GAMP-5 and EU Annexure 11( Led the CSV projects which includes Empower-3, Chromeleon 7.2, Trackwise, BMS, MES, LMS and other production and Laboratory software’s) , along with a deep understanding of Quality redeployment processes. My proficiency extends to conducting comprehensive investigations and implementing robust Quality Management Systems that align flawlessly with current regulatory requirements.
Throughout my career, I have had the privilege of collaborating with esteemed consultants such as NSF, Lachman, Parexel, PwC, Quanta, PQE, and DNV, enriching my knowledge and adopting best practices in the industry. Notably,
I have spearheaded Operational Excellence initiatives that have consistently led to impressive business growth, ranging from 15 to 30%, supported by a proven and meticulous methodology.
Experience
Principle Consultant-PQE Mar-2022 to Till date
- Lead GMP auditor – handling vendor audits and gap assessment (EU-GMP) audits
- Site assessment of QA/QC Production procedures vs practices
- Develop procedure for electronic data and audit trial management
- Conduct workshop on Data Integrity and Human Error
- SOP gap analysis and simplification (Corporate SOPs & Site SOPs)
- Handle Operational Excellence Projects
- Equipment qualification of production instruments
- Train staff on CSV, CSA, Human Error, GMP, Audit behavior and GLP
German Multinational field of Research & Development, manufacturing of world-class oncology drugs
Head-QC
Reporting to M.D
Managed QC Team of 80 - handled QC for 5 plants manufacturing APIs for Oncology drugs
- Complete ownership of quality control process, GLP implementation and regulatory compliance
- Mentor QMS and Investigation (OOS/OOT/OOC) teams Ensure investigations are closed in time, CAPAs generated
- Develop QC program to meet regulatory requirements
- Maintain quality for RM/PM/IP/FP/ stability samples
- Conducting cGMP audits to ensure compliance
- Assess performance of vendors
- Ensure qualification of all the analytical instruments and validation of Software pertaining to QC as per GAM5
- Validations (Process and Method) , CAPA Deviation management
An US multinational, engaged in development of sterile pharmaceutical drugs, contract manufacturing
Head – General Manager, QC – (Sterile & Injectable)
(Four Blocks: Hormone, Carbapenem, Cephalosporin and General)
Reported to VP Head Quality; handled QC for 4 plants with a QC team of 145
- Established new cGMP quality control lab and microbiology lab, completed USFDA filing as per regulations
- Completed the entire QC automation process before deadline
- Successfully handled international consultants for 1.5 years (NSF, RCA, PQE) to complete the remediation process
- Got AKORN Award for Superior Performance in Compliance Culture Revamping conducted last two years
Steril-Gene Life Sciences Pvt Ltd (Sterile Dry Powder, Injection and Solid dosage) April’14 to Mar ‘15
Head – General Manager, QC
(Four Blocks: Hormone, Carbapenem, Cephalosporin and General)
Managed 5 plants in Puducherry manufacturing sterile injectables, with a QC team of 185
- Developed QC procedures and policies for International regulatory approval along with other job responsibilities
Manager – Corporate Quality (Audit &Compliance)
Spearheaded Audit and Compliance operation of 5 sites which included, API, Ophalmic, Dry Powder, Injection and Solid dosage/ Developed corporate assurance policies and centralized Sop’s
- Established and Qualified new laboratories (Chemical and Microbiology)
- Harmonized the SOPs and QA/QC procedures between the 5 plants to ensure regulatory compliances were met
- USFDA warning letter and import alert were lifted out through proper CAPA
- Supervised the scale up, transition from R&D to production and GMP/GLP compliance
- Managed audit preparation for Internal, regulatory audits such as USFDA, MHRA, WHO, MCC, TGA ANVISA and ISO
Sr. Research Associate – II (Sr. Group Leader)
- Completed set-up of cGMP Lab in BIOCON Bristol-Myers Squibb Research Centre
- STAR Award from Bristol-Myers Squibb-US for efficient and timely delivered Method Developments
- Received Milestone Award from Bristol-Myers Squibb-US for outstanding contribution to get new active Drug
Hikal Limited, Bangalore (API-QC, AR&) Executive – Quality (QA / QC) Aug’03 to Apr’05
Global Remedies Limited Sr. Chemist – QC Aug ‘95 to Aug ‘03
Education
Ph.D. Chemistry from Sri Satya Sai University for Technology and Medical Science Bhopal - 2022
MBA from Sikkim Manipal University in 2011
M.Sc. (Chemistry) from Bharathidasan University in 1995
B.Sc. (Chemistry) from Bharathidasan University in 1993
