QA Manager & QP
SIRE Life Sciences®
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SIRE® 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 Oost-Vlaanderen Belgium.
Role Description Drug product development of new drug candidates focusing on difficult to formulate drugs that are in preclinical, phase I or phase II clinical development. The company offers a full suite of drug development services encompassing preclinical development, preformulation development, formulation development, analytical development, dosage forms development, scaling-up and GMP manufacturing of chemical and biologicals drug candidates
Responsibilities You implement, maintain and manage a GMP compliant Quality Management System for manufacturing and quality control of biological drug substances and related final products (buffer preparation, upstream and downstream processes) based on applicable regulations and guidelines.
You manage the CAPA system: changes, deviation, non-conformities.
You manage, support and coordinate risk assessments.
You manage the supplier qualification process (materials and services).
You support and review the qualification of production equipment, test equipment and cleanroom facility.
You lead audits and inspections.
You will review and approve batch records.
You will release batches of biological intermediate products, drug substances and related final products (Investigational Medicinal Products).
As a Qualified Persons you certify final products (Investigational Medicinal Products).
You promote the awareness of quality, regulatory and customer requirements throughout the company.
Requirements Master of Science degree in pharmaceutical sciences, chemistry, biochemistry or related discipline
You are registered as a Qualified Person
10 years of quality assurance experience in the pharma and/or biotech industry.
Knowledge of GMP quality system and regulatory requirements (Eurdralex, ICH)
Knowledge of biological process development and manufacturing is a real asset
Excellent organization, facilitating and coordination skills. Ability to work independently as well as a member of a team in a dynamic environment
Strong decision making and problem-solving skills
Excellent oral communication, reporting and presentation skills
Fluent in Dutch and English, written and spoken.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Greg Silberstein.