kaushik gupta

Core Competencies:

• A seasoned Operational Industry Leader with more than a decade plus years of experience

leading teams through high profile, high stress, and fast paced environments.

• Expertise in CSV Driven technologies, Software Applications of Life Sciences,

qualifications and validations of Equipments, Facilities, Utilities and Systems.

• Strong knowledge of regulatory compliance, including 21 CFR Part 11.

• Proficient in handling the greenfield projects and Facility Layout suggestions.

• Extensive experience with quality management systems and audits (USFDA, WHO,

INVIMA, MHRA, EMA and Many country Audits as mentioned below).

a) USFDA

b) WHO Geneva cGMP for prequalification of oral Bio Polio Oral Vaccine

(OPV)

c) e) Ukraine country Audit for qualification of Rabies Vaccine

d) CDCSO (India)

f) INVIMA Colombia pre audit & Several Country Audits like Ukraine, Malaysia and Nigeria

• Vast knowledge in guidelines like USFDA 21 CFR Part 11, ICH Quality, PDA, ISO, EN285, HTM 2010 and Schedule M, EMA etc.

• Quality Management systems- Sustaining the process with required CAPA actions and remediation plan to prevent the recurrence of risks identified.

• Implementation of eQMS at multiple organizations.

• Skilled in stakeholder management and leading cross-functional teams.