Role Overview
To maintain and continuously improve the affiliate quality system in compliance with Roche Pharmaceutical Quality System requirements, local GxP-regulations and applicable ISO-standards whilst ensuring an uninterrupted supply of quality products to patients.
Key Responsibilities
- QMS Management: Conduct regular management reviews of the QMS by presenting and tracking performance against relevant standards.
- SOP & ISO Implementation: Implement quality systems in line with ISO and relevant standards by reviewing and understanding divisional SOPs, analyzing their impact on the local environment, and executing relevant aspects as required.
- Discrepancy & Change Management: Identify discrepancies, investigate them within quality systems in a timely manner, and manage changes to processes, personnel, or systems by evaluating impact and communicating as needed.
- CAPA & Risk Assessment: Propose, execute, and monitor Corrective and/or Preventive Actions (CAPA) and conduct quality risk assessments using quality risk assessment tools to mitigate or eliminate risk areas.
- Data Integrity & Audits: Maintain and implement SOPs that ensure data integrity. Initiate/support self-inspections and external audits, identify audit queries, draft audit reports, and follow up on agreed corrective actions.
- Product Recall & Complaints: Coordinate annual mock recalls and actual product recalls with Health authorities and distributors. Monitor generic product complaint mailboxes and manage received complaints based on standard SOPs.
- Product Release: Release commercial batches to the local market and Investigational Medicinal Products to the local clinical trial sites according to regulations, Marketing Authorizations, and Clinical Trial Authorizations.
- Distribution & Supply Chain Support: Support returns, batch traceability, cold chain management controls, and oversee GxP suppliers and third-party logistics/warehouse business partners to ensure compliance with quality agreements.
- Stakeholder Engagement: Collaborate with internal and external stakeholders to provide input and build skills on quality standards and procedures.
Who Are You?
- Education: University degree in pharmacy, medicine, pharmaceutical chemistry and technology, biology, or related science disciplines.
- Experience: 3 - 5 years of experience in a pharmaceutical or medical device environment, Regulatory, and Quality Assurance Management.
- Compliance: Proven ability to uphold and maintain rules and SOPs.
- Knowledge: Deep understanding of current regulatory frameworks, pharmaceutical Quality Management Systems, and ISO standards.
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