Specialist QA
il y a 3 jours
**Introductie**:
For our client, a Biotech company with high-quality standards we are looking for a Specialist QA / Qualified Person.
You will play an important role in ensuring that the produced medicines meet the highest standards and align with regulatory requirements, to ultimately reach there patients in Belgium and Luxembourg.
The purpose of the role is to be part of the International Distribution & Quality, in charge of creating, maintaining the quality management system
**Jobomschrijving**:
- Carry out all duties in such to ensure that our client can demonstrate compliance with EU-GMP and EU-GDP
- Decide upon product release of medical product for the local market
- Ensure that suppliers are properly approved and qualified
- Review annual product quality reviews of marketed products
- Provide oversight for all aspects related to in-country product distribution and storage
- Perform a periodic review to ensure that customers are entitling to receive medicinal product
- Own, review, and approve quality-related documentation (e.g. SOPs, Forms, Training, Risk Assessments, etc)
- Initiate, Own, review and/or approve deviations, CAPA and temperature excursion, and review distribution complaints
- Perform impact assessment as part of change controls impacting local processes
- Manage/oversee product complaints handling process including incoming intake and notify complainants of complaint closure (where required)
- Decide on the final disposition of returned, rejected, re-called or falsified products
- Execute product recall at local level
- Contribute to and drive continuous improvement and digital innovation projects in cross-functional collaboration
- Participate in or lead internal audits and regulatory inspections
- Assist in the development and delivery of GMP/GDP training for local staff
- Ensure that any additional requirements imposed on certain products by FAMHP and national law are adhered
**Profiel**:
- Master in Pharmaceutical Sciences
- Registration on the list of Qualified Persons as required per RD 14/12/2006
- Minimum 3 years’ experience in Quality Assurance in the pharmaceutical, biotechnology, or medical devices industry in affiliate setting
- Previous practical experience in Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)
- Knowledgeable and skilled to fulfill the requirements of EU directive 2001/83/EC article 49 (Qualified Person)
- Knowledge on Belgian and Luxembourg regulations in relation to Manufacturing, Importation, Wholesale Distribution, Import, Export and Foreign trade, Guidelines on Good Manufacturing Practice (EU GMP) (Eudralex Volume 4), Guidelines on Good Distribution Practice (EU GDP) of medicinal products for human use (2013/C 343/01), European Community Directive D2001/83/EC relating to trade abroad activities, European Falsified Medicines Directive (2011/62/EU), and the European Pharmaceutical Directive related to Wholesale Distribution of Medicinal Products (92/25/EEC)
- Ability to problem solve and make scientific risk-based decisions
- Demonstrated proficiency in written and verbal communication skills (including technical writing and presentations) with the ability to effectively communicate and collaborate with production and technical staff
- Fluency in English; Dutch and French as beneficial
**Aanbod**:
Join them in there commitment to quality, and together, let's elevate patient care. This is your chance to thrive in an environment where quality is at the heart of everything they do.
In addition to the base salary, the company offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
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