Browse by job sector

Document Review Specialist

  1. North America, East Coast
North Carolina
  1. Contract
Competitive
  1. Compliance / Quality Assurance
37009
Apply to this job Save job
Document Review Specialist - US, North Carolina - 6-12 Month Contract

Our client, a global pharmaceutical manufacturing organization are looking for a talented Document Review Specialist to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.

Essential Duties and Responsibilities for this role include, but are not limited to:
  • Ability to read and understand CQV and site quality procedures and align with the clients operating principles and regulatory requirements.
  • Ability to work with an electronic validation system such as KNEAT or similar systems.
  • Conduct GDP reviews of test protocols pre and post execution to facilitate a timely review and approval process with Quality.
  • Utilize and own GDP checklist to track errors found in protocols and other documents. Update checklist as needed to ensure comprehensive list of potential GDP errors.
  • Conduct general documentation reviews of specifications, design documents, procedures, work instructions, etc. to ensure GDP requirements are met and standard formatting is maintained.
  • Liaise with CQV Leads, CQV Engineers and other departments to resolve GDP errors in protocols and documents.
  • Train CQV teams on GDP standards.
Requirements:
  • Extensive experience in a similar documentation review and/or Quality Assurance role for cGMP Documentation.
  • Prior experience with cGMP or in other highly regulated industries such as on Large Scale Projects and/or GMP operational facility.
  • Experience with liaising with other departments and engineers/QA
  • Strong communication skills and ability to escalate issues as needed.
  • Strong knowledge and experience successfully executing complex projects in a Pharma/cGMP environment.
  • Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Word)
If you are interested, please apply now for immediate consideration and further information.
#LI-NR1

Apply to this job Save job
Save as a job alert
List #1

Similar Jobs

Clean Utilities SME

Salary

Competitive

Location

Frankfurt ( Oder)

Salary

Competitive

Sector

Compliance / Quality Assurance

Job type

Contract

Location

Germany

Frankfurt

Description

Clean Utilities SME - Germany, Frankfurt - 18 Month Contract  We are recruiting on behalf of a leading global pharmaceutical client based in the surroundings of Frankfurt. Due to a large capital

Reference

37484

Expiry Date

01/01/0001

Amy Baxter

Author

Amy Baxter
Amy Baxter

Author

Amy Baxter
Read more
Read more
Low Voltage Electrical Engineer

Salary

Competitive

Location

Frankfurt ( Oder)

Salary

Competitive

Sector

Compliance / Quality Assurance

Job type

Contract

Location

Germany

Frankfurt

Description

Low Voltage Electrical Engineer - Germany, Frankfurt - 18 Month Contract  We are recruiting on behalf of a leading global pharmaceutical client based in the surroundings of Frankfurt. Due to a

Reference

37483

Expiry Date

01/01/0001

Amy Baxter

Author

Amy Baxter
Amy Baxter

Author

Amy Baxter
Read more
Read more
Senior Project Manager

Salary

Competitive

Location

Dublin

Salary

Competitive

Sector

Compliance / Quality Assurance

Job type

Contract

Location

Ireland

Dublin

Description

Senior Project Manager - Ireland, Dublin - 12 Month Contract Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Senior Project Manager. A leader in the

Reference

37479

Expiry Date

01/01/0001

Abigail Stier

Author

Abigail Stier
Abigail Stier

Author

Abigail Stier
Read more
Read more

Insights

A Day in the Life of a Quality Assurance Specialist in the Pharmaceuticals World

A Day in the Life of a Quality Assurance Specialist in the Pharmaceuticals World

Read more

10/27/2023

Your next step as a Validation Engineer
Read more

07/20/2021

Pennsylvania skyline

Living and working in Pennsylvania
Read more

06/24/2021

VIEW ALL

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.

Send your CV
Upload your CV