As a Sr. Associate QA, you will provide QA oversight in the clinical production area. In addition, you will support quality processes related to warehousing for clinical and commercial products at our site and outsourced partners. You will be in direct contact with a wide range of stakeholders, and be responsible for establishing effective working relationships with key stakeholders including Global Clinical Supply Chain (GCSCM), Warehouse/Distribution, Production and Site Quality.
What are your responsibilities?
In this role you act as a Sr. Associate QA, you are mainly responsible for providing quality guidance in the warehouse and clinical production area, assuring that GDP and GMP standards are maintained. Your key tasks will be :
- Responsible for batch review to support QP batch certification of Investigational Medicinal Products in compliance with EU and international regulations
- Provide daily guidance and support to Production staff in regard to compliance with Standard Operating Procedures and Work Instructions
- Act as a first point of contact in case of production queries (quality-related) during packaging and labeling operations.
- Perform finished product checks during production runs
- Perform GMP compliance checks in production
- Assist in the resolution of compliance and quality issues related to the manufacturing and warehousing
- Responsible for QA oversight of the internal and external warehouse, including but not limited to compliance checks in the warehouse, damage inspections, distribution complaints, and review of temperature data;
- Review and approve minor deviations ensuring all procedural requirements are met
- Owning and generating operational SOPs and Work Instructions
- Review of SOP’s ensuring that Corporate, Site and Regulatory requirements are met
- Responsible for the preparation of monthly metrics
- Identify issues and work cross-functionally to ensure a solution
What do you need to be successful in this role?
- MBO or Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience
- Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review, investigations and analytical testing
- Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/or Good Clinical Practice (GCP) knowledge
- Fluent in English.
Interested? Send me your CV at email@example.com. Let's get in touch ASAP.
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