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Supply Chain QA Manager - Pharma
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Biotechnology and Pharmaceutical organization, based in Basel-Stadt Switzerland.
Our client focuses on Orphan diseases.
Act as quality contact to all affiliates worldwide and maintain close relationships with local quality counterparts
- Actively support the Affiliates in establishing and maintaining a local quality system;
- Keep abreast of developments in the Affiliates as well as local regulations/requirements in the respective countries
- Contribute to the organization and the content of the yearly global quality event
- Support in preparing, managing and following up on local GDP regulatory authority inspections.
- Conduct audits of affiliates as well as audits and assessment of business partners in countries with no affiliates (on quality system, Pharmacovigilance and Good Distribution Practice, as appropriate)
- Evaluate and approve corrective actions related to audit findings;
- Conduct GDP assessments and audits of local distributors on behalf of Affiliates, if needed.
- Develop and maintain procedural documents for Post-Marketing Quality Assurance;
- Participate to the development of corporate SOPs as appropriate.
- Cross-functional Projects
- Represent Post-Marketing Quality Assurance at cross-functional projects (e.g. implementation of new quality system for deviation handling).
- University degree in a business or scientific field
- 4 years of experience in a regulated (GxP) additional QA/auditing experience preferred
- Knowledge of international pharmacovigilance regulations/guidance documents and understanding of their practical implications
- Sound understanding of the various GxP regulations, in particular GDP
- Available to travel 20% of the time
- Fluency in written and spoken English.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.