We are looking for a detail-oriented and proactive colleague with strong communication skills and the ability to work effectively under pressure. Experience in a Good Manufacturing Practice (GMP) environment is an advantage.
Objectives
Perform QA reviews and approvals of SAP Master Data and artwork.
Ensure QA systems are maintained, continuously improved, and appropriately monitored.
Establish effective working relationships with the Global Artwork Center, Master Data, SCPM, Site SMEs, Regulatory Affairs (RA), and QA Management.
Key Responsibilities
Review and approve Master Data-related activities, including critical value verification and Bills of Materials (BOMs).
Approve artwork for medicinal products.
Act as an author of operational SOPs and Work Instructions.
Perform QA reviews of operational SOPs and Work Instructions.
Participate in QA-related projects as required.
Assist with investigations as needed.
Prepare weekly and monthly performance metrics.
Own and maintain departmental performance boards.
Problem-Solving
Apply research, information-gathering, analytical, and interpretation skills to problems of varying scope.
Ensure compliance with applicable regulatory requirements.
Develop solutions to technical problems of moderate complexity.
Screen, categorize, evaluate, reconcile, report, and resolve data integrity issues.
Interpret established practices and methods.
Autonomy
Work under general direction, guided by departmental or assignment objectives.
Refer to technical standards, principles, theories, and precedents as needed.
Set project timelines and priorities based on objectives and ongoing assignments.
Recognize and raise issues appropriately.
Contribution
Ensure the quality of assigned tasks and services.
Contribute to the achievement of project milestones and departmental objectives.
Provide training and guidance to colleagues and act as a technical or scientific resource within the team.
Establish effective working relationships with stakeholders outside the immediate area of expertise.
MBO qualification or a bachelor's degree in Life Sciences or a related field, or an equivalent combination of education and experience. Candidates with a master's degree in Life Sciences may be considered at entry level.
Typically, three years of relevant Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry.
Knowledge of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and or Good Clinical Practice (GCP), with the ability to interpret and apply requirements in routine situations.
Fluency in English, both written and spoken.
Strong attention to detail and accuracy.
Preferred Requirements
Fluency in both Dutch and English, written and spoken.
Location Breda, Netherlands.
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Senior Quality Assurance Associate in Breda werkgever: Panda International
Als werkgever in Breda biedt ons bedrijf een dynamische en ondersteunende werkomgeving waar medewerkers de kans krijgen om hun vaardigheden in supply chain planning te ontwikkelen en te verbeteren. We stimuleren een cultuur van samenwerking en continue verbetering, met mogelijkheden voor persoonlijke groei en professionele ontwikkeling. Met een focus op standaardisatie en procesautomatisering, zijn we toegewijd aan het creëren van een efficiënte en stabiele operatie die bijdraagt aan de gezondheid van patiënten in bijna 100 markten.
