QA senior specialist DP
Vor 6 Tagen
A key client of BioTalent are looking to onboard a QA specialist for drug product on a permanent full time basis.
Responsibilities include:
- Act as a
subject matter expert in Quality Assurance
for drug product manufacturing and Quality Management Systems (QMS), ensuring compliance with cGMP and regulatory expectations. - Review and approve batch records
and related documentation; prepare batch release documentation for the Responsible Person / Qualified Person (QP) and support QP release activities. - Apply
strong knowledge of drug product processes
, including sterile and non-sterile manufacturing, packaging, and visual inspection, to assess quality risks and drive compliance. - Continuously improve and maintain the QMS
, leading or supporting initiatives to enhance quality processes, efficiency, and inspection readiness. - Represent QA in audits and inspections
, serving as a key interface with internal and external stakeholders and regulatory authorities. - Build
collaborative, cross-functional relationships
, working proactively with production, validation, and development teams to resolve issues and ensure quality objectives are met. - Demonstrate a
balanced, team-oriented mindset
, placing collective goals above individual interests and contributing to a calm, solution-driven work environment.
You will have:
- Experience in quality assurance for at least 5 years in pharmaceuticals/biopharmaceuticals
- Experience in Drug manufacturing environment / GMP
- Experience in interacting with all kind of interfaces within the organization as well as with regulatory agencies (Swissmedic, FDA etc.)
- Fluency in English language required, good German language skills would be an advantage
- Subject matter expertise in QA (Drug product) and QMS
Reach out directly to for further information.
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