Pari Subash

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.

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

Fresenius Kabi Oncology Ltd Jan ’20 to Feb ‘22

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 

Akorn India Pvt Ltd (Sterile Powder and Injectable) Paonta Sahib, Himachal Pradesh Mar’15 to Jan ‘20

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

Received Employee Retention Award from AKORN, 3 increments for good performance

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

Micro Labs Ltd., Bangalore May’11 to Apr’14

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

Biocon BMS R&D Centre, (AR&D), Bangalore Apr’06 to May’11

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

Apotex Pharmachem India P Ltd., Bangalore (API-QC&AR&D) QC – Lead May’05 to Mar’06

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

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