Senior Associate QA (GMP) (35358)

Orion Group Life Sciences are looking for a Senior Associate QA (GMP) for our Multinational Pharmaceutical/Biotechnology client based in Breda. Initial 12-month contract, with a high possibility of extension. Hybrid role.

Role Summary

Our client is seeking a Quality Complaints Sr. Associate to own complaint records, supporting the Product Complaints and Surveillance Team. 
The Product Complaints and Surveillance team is a global team that owns and executes the end-to-end global complaint process and management system, ensuring appropriate business connection across our client. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.
As a Sr. Associate QA Complaints, your role will involve overseeing complaint management, including conducting assessments, in accordance with Complaints Procedures and Regulatory Guidelines. Additionally, you will be tasked with establishing timelines for the completion of investigations.

Main Responsibilities of the role

• Initiate and own product quality complaints investigations, and safety quality investigations for our client commercial and/or clinical products.
• Ensure complaint investigation assessments are completed accurately and on time.
• Partner with assessors from other sites of our client and contracted suppliers/ manufacturers to resolve product complaints investigations.
• Escalates potential Quality issues to Management.
• Participate in site regulatory inspections of the complaint handling process and in audits (internal and third party) as required.

Required Qualifications and skills

• Master’s degree OR Bachelor’s degree in a science field and 2 years of Quality experience OR
  Associate’s degree and 6 years of Quality experience OR High school diploma / GED and 8 years of Quality experience.
• Quality and manufacturing experience in biotech or pharmaceutical industry.
• Ability to successfully manage workload to timelines.
• Familiarity with basic project management tools.
• Demonstrated ability to consistently deliver on-time, and high-quality results.
• Ability to operate in a matrixed or team environment.
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).

If you would like to have a confidential conversation regarding this opportunity, please reach out to Tim Browaeys, tim.browaeys@orion-jobs.com or contact Tim on 0044 7593448607
 
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