Senior Principal Scientist - Clinical Quality Auditor at Dechra Pharmaceuticals PLC
Overland Park, KS 66211, USA -
Full Time


Start Date

Immediate

Expiry Date

11 Jun, 25

Salary

0.0

Posted On

11 Mar, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Good communication skills

Industry

Pharmaceuticals

Description

Job Introduction
Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra!
Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
Our values are embedded within our culture and thrive within our family of almost 3000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business.

Responsibilities
  • Responsible to coordinate preparation activities for regulatory authority inspections to enable inspection readiness at clinical sites· Conduct Vendor Audits of third party laboratories, Contract Research Organizations and other Product Development (R&D) supporting vendors (e.g. bioanalytical services, clinical supply services)
  • Provide general quality guidance and compliance consultation
  • Generate/Author Clinical Quality Assurance Standard Operating Procedures and Policies and provide review for supporting Policies and Procedures
  • Responsible to establish and execute quality plan/audits for Dechra clinical trials.
  • Provision of regulatory training for Product Development Organization
  • Provide Sponsor QA oversight of GLP studies conducted by third party laboratories
  • Serve as Clinical Quality Representative on Dechra Product Development Project teams
  • Comply with all Dechra local and global policies including quality frameworks, Code of Conduct, anti-discrimination/harassment and health, safety, and environment (HSE) policies
  • Perform any other duties or serve in such other capacity as may be determined by company management
  • Serve as Sponsor Quality for clinical efficacy studie
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