Conducts in-depth audits ensuring compliance with industry standards and regulatory frameworks, identifies gaps, and offers actionable recommendations for continuous improvement.
Oversees product release, ensuring that each batch meets stringent regulatory requirements, safeguarding patient safety and product integrity.
Ensures compliance with pharmaceutical distribution activities, maintaining a secure supply chain while meeting all regulatory obligations.
Provides expert guidance on Good Manufacturing Practices (GMP) to maintain high standards of product quality and regulatory compliance throughout the production process
Ensures Good Distribution Practices (GDP) are upheld, securing the integrity of pharmaceutical products across the entire supply chain.
Navigates the complexities of the Medical Device Regulation (MDR), ensuring medical devices meet the necessary legal requirements for market approval.
Leads and sustains a company-wide culture of quality, implementing robust systems and ensuring compliance with regulatory and customer requirements.
Drives complex quality-focused projects from conception to completion, ensuring all deliverables are met on time and within scope.
Spearheads remediation activities to address compliance gaps, restoring and improving operational and regulatory performance.
Develops, implements, and optimizes Quality Management Systems (QMS), aligning processes with regulatory standards and business goals.
Monitors and enhances quality assurance processes, ensuring compliance and maintaining consistent product quality throughout the organization.
Executes precise quality control testing and analysis, ensuring that products meet all required specifications and regulatory standards.
Manages Computerized System Validation (CSV) processes, ensuring that digital systems meet regulatory requirements and perform as intended.
Conducts equipment qualification and process validation, ensuring systems operate within predefined parameters and meet regulatory expectations.
Delivering Quality isn’t just what we do at Biolumnis—it’s who we are. Quality is deeply embedded in our culture, shaping both our core values and our identity. Contact us for an intake and explore our expertise.
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About us
Contact
Ridderhof 100
5341 HS Oss
info@biolumnis.nl
+31 412 712 092
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Biolumnis
Ridderhof 100
5341 HS Oss
+31 412 712 092
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