Senior Associate QA
SIRE® Life Sciences
Senior Associate QA
Samenvatting
Wat krijg je?
Wat ga je doen?
- SAP Master Data activiteiten controleren en goedkeuren
- Artwork van geneesmiddelen beoordelen en goedkeuren
- Operationele SOPs en werkinstructies schrijven
- Kwaliteitscontroles uitvoeren op SOPs en instructies
- Deelnemen aan QA-projecten en verbetertrajecten
Wat verwachten wij?
- Bachelor degree in Life Sciences or related field
- Three years of QA or pharmaceutical manufacturing experience
- Knowledge of GMP, GDP and GCP regulations
- Experience in regulated pharmaceutical or medical environments
Volledige vacaturetekst
At this global pharmaceutical leader, the NL CW Senior Associate QA plays a vital role in safeguarding patient safety and product quality. You will oversee critical SAP Master Data and artwork approvals within a high-stakes GMP environment. Joining this organization means contributing to life-changing healthcare while participating in innovative quality projects and continuous improvement. Dive into a world of operational excellence and elevate your quality career today.
The Company
A global organization operating within the pharmaceutical and life sciences industry, focused on maintaining high quality standards across manufacturing, supply chain, and regulatory processes. The company works in a highly regulated environment where compliance, product quality, and patient safety are critical priorities.
About the Role
The NL CW Senior Associate QA is responsible for supporting Quality Assurance activities related to SAP Master Data and artwork approval processes. The role ensures compliance with GMP requirements while maintaining data integrity and operational excellence. This position works closely with cross functional teams including regulatory affairs, supply chain, master data specialists, and quality management to support business objectives and continuous improvement initiatives.
Responsibilities
- Perform QA review and approval of SAP Master Data activities including critical value verification and Bills of Materials
- Review and approve artwork for medicinal products
- Author operational SOPs and Work Instructions
- Conduct QA review of SOPs and Work Instructions
- Participate in Quality Assurance projects and continuous improvement initiatives
- Support investigations and issue resolution activities
- Prepare weekly and monthly quality metrics reports
- Own and maintain departmental performance boards
- Monitor QA systems and recommend improvements
- Collaborate with Global Artwork Center, Master Data teams, Site SMEs, Regulatory Affairs, and QA Management
- Identify, evaluate, and resolve data integrity issues
- Ensure compliance with regulatory and quality standards
- Bachelor degree or equivalent qualification in Life Sciences or a related field
- Approximately 3 years of Quality Assurance or pharmaceutical manufacturing experience
- Knowledge of GMP, GDP, and/or GCP regulations
- Experience working within regulated pharmaceutical or medical device environments
- Excellent communication and stakeholder management skills
- Ability to work effectively under pressure
- Experience with SAP Master Data processes is advantageous
- Fluent English & Dutch language skills
59196
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