Dharmi Trivedi

Phone: 516-***-****

E-mail: addyxe@r.postjobfree.com

Expertise Summary:

Over 20 years of experience in pharmaceutical industry including, Quality and Compliance, Quality Control and R & D.

Experience:

Bausch Health Company, Bridgewater, NJ

Sr. Manager, EMQA Operation 01/2020 to 06/20

-Managed and lead external manufacturing quality (EMQA) operation team, provided leadership in supporting quality disciplines, decisions, and practices for the external manufacturing quality team.

- Ensured the timely delivery of the product to company’s distribution centers

- In conjunction with internal teams, worked to resolved challenges with external manufacturers

- Proactively investigated, identified, and implemented best-in-class quality practices

- Established process model for quality improvement and provide training to organization personnel

- Mentor and lead quality professionals within team to provide growth and development

- Informed senior management on an ongoing basis about the performance of company’s external manufacturing network

Acorda Therapeutics, Ardsley, New York

Sr. Manager, QA GMP 04/2015 to 10/19

Job duties include managing all Quality Assurance third parties contracted to perform any functions in support of the CGMP manufacture of clinical supplies and commercial product.

-Plan and conducts CGMP audits of manufacturing activities to assess compliance with all pertinent regulations as well as with company SOPs.

-Performing batch release activities for products manufactured by third parties.

-Review investigations conducted by third parties and provide Acorda with input into CAPAs taken by the third party. Track investigations to ensure timely closure.

-Working closely with Technical Operations and Research & Development to identify, evaluate, and recommend solutions to issues identified in the performance. Provide QA input to technical transfer activities.

-Create new SOPs/Revisions to existing SOPs as needed.

-Review/approve Annual Product Review (APRs) reports.

• Data Integrity-QC Lab. • Change control/Investigations/CAPAs

• Contractor GMP audits including domestic and

international for API manufacturer and Finished

products manufacturer

• Installation and Qualification for stability

chambers and data monitoring system

• Product Release

• QA support during Tech. transfers

• Familiar with FDA, ICH Guidelines and 21 CFR

part 210 & 211, part-11 Part 820 and ISO 13485

• FAR and Recalls

• Process validation

• Review CMC section for IND,NDA and ANDA

• Batch Record review

• Stability Program including Clinical Trial Material

(CTM)

• Analytical method development and validation

• QA Agreement

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Dharmi Trivedi

Phone: 516-***-****

E-mail: addyxe@r.postjobfree.com

-Participate in the preparation and review of CMC sections of regulatory submissions.

-Work with the management of Quality to assure alignment and compliance with the company quality management systems

-Coordinate and prepare for Pre-Approval inspections at CMOs.

-Represented QA on Serialization project

-Represented QA on Veela software team for QMS implementation, review/approve Master validation plan, User requirements, test scripts, and qualification protocol/reports. Lachman Consulting Services, Westbury New York 06/2014 –04/-2015 Consultant

Provide quality and compliance services to pharmaceutical companies (Lachman’s Clients) on as needed basis. Quality and Compliance services include conducting GMP audits that include Mock PAI and Due diligence audits.

Endo Pharmaceuticals, Westbury New York

Principal QA Specialist 2009-2013

-Followed and maintained quality assurance processes, procedures and controls ensuring that performance and quality of products conform to established standards.

-Independently conducted internal and external audits including drug products manufacturers and API suppliers.

-Initiate and complete through approval of QA agreements with contract manufacturers

- Responsible for release of marketed products

-Responsible for change control, investigations and CAPAs

- Provided regulatory support in relation to any Field Alerts and Recalls to ensure regulatory compliance, evaluating product quality complaints with regards to filing FARs and ensuring compliance with Federal and State regulations.

- Provide regulatory feedback on manufacturing change controls and ensure any specific commitments filed in regulatory filings are fulfilled on time.

-Participated in remediation and CPAT plan

-Review and approve APRs

Endo Pharmaceuticals, Garden City, New York 2006-2009 Sr. QA Specialist

-Review and approval of equipment, batch records and product validation protocols and reports

-Responsible for release of clinical supplies for Phase I-IV Clinical trials

-Responsible for all GMP aspects of the Part 11 remediation plan

-Served as a chair person on Product Quality Review Board (PQRB)

-Review/approve Annual Product reports (APRs)

-Reviewed CMC section for NDA and ANDA applications and provide QA input

-Conducted internal and external audits to API and finished product facilities Senior Quality Engineer 1998-2006

-Key member of drug development CMC team

-QA interface between R&D and Manufacturing

-Responsible for release of clinical supplies for Phase 1-IV Clinical trials

-Review and approve change control and investigations

-Responsible for FDA Pre-Approval Readiness for R&D Divisions for ANDA/NDA submissions

-Lead quality investigations and implement systematic corrective actions

-Responsible for trouble shooting and improving the GMP compliance of a key vendor API facility Page 2 of 3

Dharmi Trivedi

Phone: 516-***-****

E-mail: addyxe@r.postjobfree.com

DuPont Pharmaceuticals, Garden City, New York

Staff Scientist 1993-1998

-Review and approve process validation protocols (oral liquids, tablets, soft gelatin capsules and APIs)

-Responsible for Technical Transfer of new products from R&D to Manufacturing

-Managed stability program

-Analytical Method validation

-Perform Source Data Audits and MOCK PAI audits in preparation to PAI for NDAs and ANDAs

-Served as a chair person on stability review board (SRB)

-Served as a Quality representative on Endo labeling committee (ELC) Pfizer INC, Brooklyn, New York

QC Chemist 1992-1993

-Responsible for diversified analysis of pharmaceuticals finish and in-process product

-Responsible for Performing stability testing, familiar with lot release system and computer application. Very familiar with Hewlett Packard’s HPLC systems, Waters HPLC systems, Hewlett Packard’s and Waters PDA(Photo Diode Array detector), UV/Vis, TGA, dissolution. Education:

M.Sc. Organic Chemistry Saurashtra University India B.Sc. Chemistry Saurashtra University India

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