Senior associate QA
Hays
Senior associate QA
Samenvatting
Wat krijg je?
Wat ga je doen?
- Perform batch record review for certification
- Approve clinical label artwork compliance
- Assess clinical product temperature excursions
- Support investigations and quality resolutions
- Approve minor deviations and compliance
Wat verwachten wij?
- Master degree in Life Sciences or related discipline
- Three years experience in QA or pharmaceutical manufacturing
- Experience with batch record review and deviations
- Knowledge of GMP, GDP and GCP
Volledige vacaturetekst
Join a leading global biopharmaceutical organisation dedicated to improving patients' lives through innovative healthcare products. In this role, you provide quality oversight for the clinical trial supply chain, ensuring compliance within a dynamic GMP environment. The project offers a 12-month contract with a clear view of extension and full travel expense coverage. Dive into the world of clinical packaging and impact global healthcare today.
Your new company
Join a leading global biopharmaceutical organisation dedicated to improving patients' lives through the development, manufacturing, and distribution of innovative healthcare products. The company operates in a highly regulated GMP environment and is committed to quality, compliance, and continuous improvement. This position is based within a dynamic production quality team, working closely with Production, Engineering, Warehouse, and Quality stakeholders.
Your new role
As a Senior Associate QA (GMP), you will provide Quality Assurance oversight for the supply chain of clinical trial products while supporting clinical packaging and labelling operations. You will collaborate with stakeholders across Global Clinical Supply Chain, Production, Warehouse & Distribution, Regulatory Affairs, Site Quality, and Clinical Research Management to ensure compliance with GMP, GDP, and regulatory requirements.Key responsibilities include:
- Performing batch record review to support QP certification of Investigational Medicinal Products (IMPs).
- Reviewing and approving clinical label artwork for compliance with regulatory requirements.
- Assessing temperature excursions during transportation and storage of clinical products.
- Supporting investigations and resolution of quality and compliance issues related to manufacturing and distribution activities.
- Reviewing and approving minor deviations while ensuring procedural compliance.
- Creating, maintaining, and improving SOPs and work instructions.
- Reviewing procedures to ensure compliance with corporate, site, and regulatory requirements.
- Preparing and reporting monthly quality metrics.
- Identifying quality issues and driving solutions in collaboration with cross-functional teams.
- Providing QA support on the manufacturing floor, including pack checks, batch record review, issue handling, and QA compliance checks during clinical packaging and labelling operations.
- Master's degree in Life Sciences or a related scientific discipline.
- Approximately 3 years of Quality Assurance or pharmaceutical manufacturing experience.
- Experience with batch record review, investigations, deviations, and analytical testing.
- Strong knowledge of:
- Good Manufacturing Practice (GMP)
- Good Distribution Practice (GDP)
- Good Clinical Practice (GCP)
- Experience working in a regulated pharmaceutical, biotechnology, or medical device environment.
- Fluent English communication skills, both written and verbal.
- Strong attention to detail and compliance-focused mindset.
- Excellent problem-solving and analytical skills.
- Ability to build effective working relationships across multiple functions.
- Proactive attitude with a willingness to learn and take initiative.
Hays Detachering | This is a project that will start with a contract for 12 months through Hays. An extension to stay within the department is anticipated. In this position, you will get a competitive salary starting at €4200 bruto per month and your travel expenses are covered.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
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