Quality Assurance Specialist - 80% remote

4 days left

Location
Leiden
Salary
Negotiable
Posted
Sep 25, 2020
Closes
Oct 25, 2020
Ref
ST260743/01
Contact
Sofie Thijs
Organization Type
Corporate
Contract Type
Contract/Freelance
Hours
Full Time

My client, one of the largest biopharmaceutical companies in the world, is looking for a Quality Assurance Specialist who can provide support in the further set-up, maintenance and implementation of their Quality Management Systems. This is the perfect opportunity to gain experience in a pharma giant which will look very attractive on your CV and can open doors for you in the future. In this role you will act as a deputy Responsible Person, so you will take on a challenging role with both a lot of freedom and responsibility in which you can prove yourself. In addition, you can largely work from home meaning that you can enjoy a very healthy life-work balance.

The main responsibility of the QA Specialist would be; acting as a deputy Responsible Person as defined in EU GDP Guidelines; performing QA activities on behalf of the Affiliate in its capacity as

wholesaler and Marketing Authorization Holder; ensuring all products, personnel and third parties conform to local QA requirements; maintain the Quality Management System; implementation and continual improvement of QM systems, procedures and processes, i.e.: handling of deviations,

complaints and CAPAs, handling of GMP/ GDP regulated changes or escalation of potential significant quality issues; complaint handling; maintain the training system for all relevant personnel; performing local checks following receipt of certified medicinal product according to a documented process and execute the local "Release for Distribution" for products in

accordance with local regulations and guidelines; perform audits; Conduct self-inspections according to the approved self-inspection plan; Ensure local GMP / GDP procedures are maintained in the Document Management Systems (ADMS); perform validation activities for local GDP / GMP systems, as required; reviewing the Product Quality Review reports in a timely manner; support the RP in case of SQI's and recalls; prepare for GDP/GMP Inspections by Competent Authorities, and assist the Quality; being the Assurance Lead & Responsible Person during these inspections.

This concerns a temporary position with a possible extension and it is definitely a door opener for great future opportunities.

What we are looking for:

  • Degree in a science/health-related subject.
  • Minimum 2-3 years experience in the pharmaceutical industry
  • Experienced in handling regulatory interfaces such as inspections and audits is an advantage
  • Fluency in written and spoken English
  • Understanding of EU GDP, EU GMP and Quality Management Systems
  • Ability to communicate and negotiate with peers
  • Understanding of local and European regulatory environment
  • Good organizational, coordination, diplomatic, negotiation, presentation and communications skills

If this job sounds interesting to you, please apply here or send your CV to me, Sofie Thijs, via the web page of NonStop consulting. You can find me on Linked In as well. If you are not available but you know someone that would be interested, please forward this to them and help out the people in your network!

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