The company:
A global biotechnology leader focused on developing innovative therapies specializes in advancing biologic medicines across areas such as oncology, cardiovascular health, inflammation, bone health, and rare diseases, with a strong emphasis on scientific research, innovation, and improving patient outcomes.
Role description :
we are looking for a Senior Associate Quality Assurance (GMP) to support product quality complaint handling and related investigations in a regulated pharmaceutical environment.
Key responsibilities
-Initiate and own product quality complaints, safety quality investigations, and product security investigations
-Partner with global/other-site QA teams and external partners to resolve investigations
-Collaborate with in-country affiliates and intake call centers on intake procedures and complaint follow-up
-Prepare, review, and approve procedures/work instructions in line with GMP, site, and regulatory requirements
-Support site projects and continuous improvement initiatives
-Provide training to internal and affiliate staff on complaint handling and investigation execution
-Initiate and own QA Non-Conformances / CAPAs where required
-Participate in audits and inspections (internal, third party, and regulatory) related to the complaint handling process
Requirements :
-MBO or Bachelor’s degree (or equivalent) with ~3+ years relevant experience or Master’s degree (or equivalent) with minimal related experience
-Fluent English
-Experience working in a regulated/GxP environment with a strong compliance mindset
-Strong analytical skills and the ability to identify, reconcile, and resolve data integrity issues
Other Information
-If you are interested and want to apply, please submit your application via the apply button below and contact me.
58316
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Prasad Nasina
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