Quality Assurance Specialist – Contract – Netherlands
I am working with a Global Biopharma to supply a Quality Assurance specialist on a contract basis to report to the QA Lead/RP
Purpose of the position
Collaboration in further setup, maintenance and implementation of the pharmaceutical quality management system as well as performance of several measures to secure the quality management of the Affiliate and its third parties.
- To act as a deputy Responsible Person
- To perform Quality Assurance activities on behalf of the Affiliate in its capacity as wholesaler and Marketing Authorization Holder
- To ensure all products, personnel and third parties conform to local, European and company quality assurance requirements
- To ensure implementation and maintenance of a Quality Management System, which is compliant with EU GDP Guidelines, local legislation and Client corporate quality assurance requirements and is proportionate to the scope of wholesale distribution and Marketing Authorization Holder activities undertaken by or on behalf of the affiliate.
- To maintain independence with regards to QA decision making within the affiliate.
Core Tasks, Responsibilities & Authority Quality Assurance Specialist
- 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.
- Ensure that deviations and complaints, as identified at the affiliate are raised in TrackWise, are appropriately investigated and CAPA plans are developed where appropriate.
- Ensure deviations, complaints, CAPAs and change control actions are progressed in a timely manner.
- Maintain the training system for all personnel involved in wholesale dealer and/or MAH activities, and perform training of the relevant Quality Management Systems.
- Perform 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.
- Check and prepare quality agreements with local country third parties in accordance with internal and external regulations.
- Perform audits of local country third parties, as appropriate.
- Conduct self-inspections according to the approved self-inspection plan.
- Ensure local GMP / GDP procedures are maintained in the Document Management Systems.
- Ensure that only approved Local Service Providers are used, if applicable.
- Collaborate with LSPs to ensure Quality Assurance requirements are followed and maintain appropriate QA oversight for GDP operations and warehouse management.
- Properly document changes with potential impact on GDP/GMP compliance, ensure that changes are approved by the RP, and implement the changes in accordance with the agreed timelines.
- Perform validation activities for local GDP / GMP systems, as required.
- Review 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 Assurance Lead & Responsible Person during these inspections.
- Prepare for QA Internal audits, and assist the Quality Assurance Lead & Responsible Person during these internal audits
- Prepare monthly KPI report, ensure approval of the KPI report by the Quality Assurance Lead & Responsible Person, and submit the KPI report to the QA Sub region lead
My Client requires an independent consultant with an understanding of EU GDP, EU GMP and Quality Management Systems that is comfortable working in a virtual contract with clients, products and colleagues.
You should be flexible and capable to do good risk assessments, show agility and not be rigid in your thinking as you will be dealing with multiple people from different countries and cultures so should be able to adapt to this.
If this sounds like you then please contact me for a full Job description, Start date is ASAP but will wait for the right person.
To apply for this role, please press the red “Apply for position” button, or contact me, Roland Schnapka on +31 (0)71 203 2098 in full confidence to receive more details on this role or to hear about other available opportunities.
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