Associate QA Clinical Manufacturing
SIRE Group
- Breda, Noord-Brabant
- Vast
- Voltijds
Our client is one of the leads from the Biotechnology industry who try to improve patients' lives, by distributing their medicines to hospital and pharmacies in 100 different countries in the world, to over 10 million patients, in Europe, Turkey, Middle East and Africa Regions.Role Description
As an Associate QA Clinical Manufacturing you will be responsible for providing quality oversight in the clinical packaging area and on the Supply Chain of Clinical Trial Products, ensuring compliance with GDP and GMP requirements.Responsibilities
– Responsible for batch review, to support QP batch certification of Investigation Medicinal Product in compliance with EU regulations.
– Compliance review and approval of clinical label artwork.
– Review and approve deviations, ensuring all the process.
– Review SOP's ensuring Corporate Site and Regulatory requirements.Requirements
– Master Science degree, in Life Sciences preferable in Pharmacy.
– Typically, 3 years of related experience in QA or manufacturing experience in pharmaceutical or medical device industry.
– Experience in batch record review, investigation and analytical testing.
– GMP , GDP and or GCP knowledge.Other information
Are you interested? Feel free to contact me!