infarAMA is currently looking for a
Safety Officer
Key responsibilities
- Comply with vigilance best practices and provide input to contribute to the evolution of the departments activity
- Stay ahead of changes in regulatory requirements in relation to safety (pharmacovigilance and materiovigilance)
- Ensure that all safety information is efficiently handled and submitted within the legally defined timelines according to standard operating procedures and working instructions
- 24/7-call handling and administration
- Case processing
- Literature screening
- Assist, review or draft aggregate reports
- Participate in self-inspections and audits
- Develop and deliver training regarding vigilance procedures to staff and contractors
- Interact with the Regulatory Affairs & Quality Assurance department
Quality Assurance Officer
Key responsibilities
- Support the Quality Assurance (QA) department
- Prepare the administrative release of finished products (medicinal products/medical devices)
- Follow-up on the implementation of new artwork
- Evaluate the destination of returned products
- Handle product complaints and deviations
- Assist in activities related to final product release by the QP (review batch documentation)
- Write and implement standard operating procedures according to customer specifications
- Ensure compliance with all applicable GDP/GMP regulations
- Prepare and provide adequate training regarding QA procedures to staff and contractors
- Participate in self-inspections and audits
- Prepare quality variation dossiers in cooperation with the Regulatory Affairs department
- Manage the QA documentation
Required profile
- Scientific degree ((industrial) pharmacist, biomedical sciences or equivalent by experience)
- Minimum 2 years of relevant experience in a similar function in the pharmaceutical industry
- Fluent in English, Dutch and French with excellent oral and written communication skills
- Strong knowledge of current software
- Meticulous, methodological, enthusiastic, flexible and reliable
- Able to work both independently and in teams
- Ability to take up RP, QP or RIP responsibility is an asset
Offer
- A varied job with challenging multi-disciplinary tasks in a dynamic and growing environment
- Competitive benefits and compensation packages
- Workplace in Aarschot or in Strombeek-Bever
Applications
Interested? Send your resume and application letter to p.vandenweghe@infarama.be.
For more information, feel free to contact us.