To support the New Product Introduction & Validation activities, we're looking for a
- Collect, prepare documentation and support batch disposition for Commercial Validation Batches (Drug Product and Primary Packaging),
- Support qualification of new Suppliers,
- Support Quality Agreement preparation,
- Support review of Master Batch Records ensuring compliance with regulatory file application
- Support Mock PAI CAPA Audit follow-up for Suppliers
- Ensure on time issuance, assessment and close out of deviations in the scope of NPI& validation
- Support implementation of NPI Change Control
- Support preparation of the Drug Product Monograph
- Perform all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements,
- Stay current with the applicable regulations and promote Quality across the organization.
- Bachelor or Master degree in Life Sciences, medical technologies or engineering
- Minimum of 3 years work experience in pharmaceutical industry, with at least 2 years in a QA department,
- Good Interpersonal skills,
- Strong work ethic and compliance,
- Good verbal and written communication skills with well-structured communication,
- English fluency written and spoken (the company language).
If you feel inspired by this challenge, please feel free to apply ! We're looking forward to receiving your application.