The Company
Our client is one of the leads from the Biotechnology industry who try to improve patients’ lives, by distributing their medicines to hospital and pharmacies in 100 different countries in the world, to over 10 million patients, in Europe, Turkey, Middle East and Africa Regions.
Role description
We are seeking a Senior Associate in Quality Assurance to oversee clinical manufacturing and supply chain operations for investigational medicinal products (IMPs). This role involves ensuring compliance with international regulations and supporting the release, packaging, labeling, and distribution of clinical trial materials. The ideal candidate will collaborate with cross-functional teams to maintain high standards of quality and regulatory compliance.
Responsibilities
- Conduct batch record reviews to support Qualified Person (QP) certification of IMPs.
- Review and approve clinical label artwork for regulatory compliance.
- Assess and document temperature excursions during transport and at clinical sites.
- Investigate and resolve quality and compliance issues related to clinical product manufacturing and logistics.
- Review and approve minor deviations, ensuring adherence to procedural requirements.
- Develop and maintain Standard Operating Procedures (SOPs) and Work Instructions.
- Prepare and report monthly quality metrics.
- Collaborate with stakeholders across supply chain, production, quality, regulatory, and clinical research functions.
- Provide on-the-floor QA support during clinical packaging and labeling operations, including pack checks and issue handling.
Requirements
- Bachelor’s degree in Life Sciences or a related scientific field.
- Minimum of 3 years of experience in Quality Assurance or manufacturing within the - pharmaceutical or medical device industry.
- Strong understanding of GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), and/or GCP (Good Clinical Practice).
- Experience in batch record review, deviation handling, and analytical testing.
- Fluent in English (written and spoken).
Other information
Apply to our vacancy for more information. Looking forward to getting in touch!
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.