Quality Investigator - Sterile GMP Facility

Highly Competitive
  1. Contract
  2. Good Manufacturing Practice (GMP)
  3. United States
St. Louis, Missouri
Posting date: 15 Feb 2019
QA.WH.21727_1550235199

ProClinical is advertising a vacancy for a Quality Investigator with one of the industry's most prestigious pharmaceutical companies. This well-renowned company, which specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas, is seeking for the Quality Investigator to join their team in St. Louis on a contract basis.

The Quality Investigator will provide guidance, coaching, and coordination for all aspects related to the initiation, tracking, trending and management of all investigations, corrective, and preventative actions (CAPA). The Investigator will work with the operations leadership team and Quality Assurance to facilitate the consistent and disciplined execution of the investigation system, ensuring the completeness and comprehension of the investigations while determining the most probably root cause. The investigator will review and analyse CAPA effectiveness through appropriate tracking and trending methods in order to prevent reoccurrence.

Job Responsibilities:

  • Investigating, writing, and closing out root cause investigations/CAPAs.
  • Implementing necessary follow-up verification checks on investigation CAPA items.
  • Coaching company colleagues to facilitate a focused knowledge transfer regarding quality investigations.
  • Reviewing the company's SOPs related to the quality investigational system and assisting with improvement/revisions.
  • Attending any investigational related meetings.
  • Investigation, writing, and closing out all investigations in accordance with company, FDA, and GMP standards.
  • Adhering to company and cGMP standards within a 30-day time frame.
  • Implementing necessary follow-up verification checks on investigation CAPA items, closing them out throughout the term of the project.
  • Investigating Root Causes, writing and implementing CAPAS, and interacting with necessary departments and people to get the job done.
  • Delivering quality investigations and thorough CAPAs in a timely manner throughout the term of the project.
  • Coaching Company colleagues to facilitate a focused knowledge transfer regarding quality investigations regularly throughout the term of project.
  • Reviewing the company's SOPs related to the quality investigational system and assisting with improvements/revisions in a timely manner throughout the term of project.
  • Attending any investigational related meetings.

Skills and Requirements:

  • A degree, preferably in a related field.
  • Demonstrable experience with quality investigation.
  • A thorough knowledge of GMP and other regulatory systems.
  • Strong interpersonal skills, including communication, persuasion, and negotiation.
  • Fluent in verbal and written English.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Will Hitchcock on +44 203 078 9554 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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