Quality Control Specialist

Location
Meath, Dunboyne
Salary
Negotiable
Posted
30 Sep 2021
Closes
28 Oct 2021
Ref
BBBH3957
Contact
Martin Taggart
Sector
Scientific
Job Type
Contract
Hours
Full-time

Manpower have an excellent opportunity for a Quality Control Specialist with 4 to 6 years of experience. This role will be based with our Biopharmaceutical client based in Meath.
Responsibilities include:

  • Supporting the qualification and validation activities and agreeing best practices in line with applicable GMP Regulations.
  • Quality SME for the execution and reporting phases of the qualification and validation activities associated with the BioNX facility.
  • Review and Approve all documentation where required specific to Qualification / Validation activities.
  • Ensure any investigations / deviations associated with the validation activities are thoroughly investigated and closed in a timely manner
  • Oversee the Project Change Management Process and approve Project Change Requests where required.



Experience required:

  • Significant experience in a QA/Validation related position within the pharmaceutical or life-sciences industry.
  • Strong experience with Validation in project related activities i.e. Experience of the Validation lifecycle particularly the qualification of process equipment, utilities and HVAC associated within a Drug Substance facility.
  • Strong experience in Validation to ensure compliance to Annex 15, EU regulations, applicable US FDA Guidelines and ASTM E2500
  • Strong experience of Computer System Validation regulations in line with 21 CFR Part 11, Annex 11 and Annex 15.
  • Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of pharmaceutical and/or biological products.
  • Track record of utilizing Risk Based Approaches to Qualification / Validation activities.
  • Strong track record of identifying, escalating and correcting compliance issues and implementing process improvements.

Apply for Quality Control Specialist

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

Marketing Communication

We would like to send you electronic communications regarding employment related opportunities, services and information that we consider suitable for you.

I would like to receive communications.

I would like you to share my personal data with other Companies within the ManpowerGroup.

You will receive an email containing the responses you have provided today with a link that will allow you to update your consent preferences at any time in the future. You can view a list of ManpowerGroup companies by clicking here.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on manpower.ie you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.

Similar jobs

More searches like this

Similar jobs