QA Manager / Permanent / Pharma / Brussels Region / Salary indication € 60 - € 80 k
Location: BelgiumSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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 Pharmaceutical organisation, based in Brussels Hoofdstedelijk Gewest Belgium.
- Be responsible and participate in GMP compliance audits;
- Collaborate with other departments (R&D, QC) to improve compliance with quality systems, internal SOPs and regulatory requirements and to resolve deviations & CAPA’s. And departements RA, clinical and non-clinical to ensure the appropriate document/data integrity for regulatory submission and preparation;
- Lead or support Document Control related processes;
- Support and conduct training for employees, as necessary.
- Be responsible for preparing trend reports related to in-process monitoring, deviation reports, investigation reports;
- Be the QA representative on project teams and for other departments;
- Evaluate compliance of completed Manufacturing records.
- Proven knowledge of GMP within the pharmaceutical environment
- Experience with regulatory inspections
- People management experience
- Negotiation and excellent communication skills
- Excellent English and French knowledge (oral and written)
Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Martijn van Nieuwenhovensss
The Company
The client put together people who are passionate about science, technology, and medicine to become leading in breakthrough therapies for life-threatening diseases.Role Description
In this role you will be responsible for all QA activities in the company and report to the global Quality Director.Responsibilities
- Leading and participate in quality assurance issues;- Be responsible and participate in GMP compliance audits;
- Collaborate with other departments (R&D, QC) to improve compliance with quality systems, internal SOPs and regulatory requirements and to resolve deviations & CAPA’s. And departements RA, clinical and non-clinical to ensure the appropriate document/data integrity for regulatory submission and preparation;
- Lead or support Document Control related processes;
- Support and conduct training for employees, as necessary.
- Be responsible for preparing trend reports related to in-process monitoring, deviation reports, investigation reports;
- Be the QA representative on project teams and for other departments;
- Evaluate compliance of completed Manufacturing records.
Requirements
- Scientific Master degree in the Life Science, approx.10 years of relevant experience- Proven knowledge of GMP within the pharmaceutical environment
- Experience with regulatory inspections
- People management experience
- Negotiation and excellent communication skills
- Excellent English and French knowledge (oral and written)
Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Martijn van Nieuwenhovensss
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