infarAMA is currently looking for a
Quality Assurance Officer
Safety Officer
Regulatory Affairs Officer
About infarAMA
infarAMA is an independent consultancy company providing high standard professional expertise in global regulatory affairs, quality assurance, vigilance and translation services to the health care industry within Benelux. infarAMA is headquartered in Strombeek-Bever and has a brand-new subsidiary in Aarschot.
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
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
Key responsibilities
- Assist and support the Regulatory Affairs department
- Prepare, verify and adapt product information
- Provide scientific support for marketing authorisation dossiers, notifications and technical dossiers
- Submit registration and notification dossiers to health authorities
- Manage the life cycle of the client portfolios (variations, renewals…)
- Proofread leaflets and labeling
- Support evaluation of promotional activities
- Maintain records and files
Required profile
- Scientific degree or relevant experience (Min. 2 years in a QA department)
- Fluent in English, Dutch and French with excellent oral and written communication skills
- Strong knowledge of current software
- Enthusiastic, meticulous, methodological, flexible and reliable
- Able to work both independently and in teams
Required profile
- Scientific degree (pharmacist, biomedical science 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
Required profile
- Scientific degree ((industrial) pharmacist, biomedical sciences or equivalent by experience)
- 1 to 3 years of relevant experience in a similar function in the pharmaceutical industry
- Ability to take up RP, QP or RIP responsibility is an asset
- Fluent in English, Dutch and French with excellent oral and written communication skills
- Strong knowledge of current software
- Enthusiastic, meticulous, methodological, flexible and reliable
- Able to work both independently and in teams
Offer
- A varied job consisting in challenging multi-disciplinary tasks in a dynamic and growing environment
- Competitive benefits and compensation packages
Applications
Interested? Send your resume and application letter to p.vandenweghe@infarama.be.
For more information, feel free to contact us.