About the Role
- Providing direct quality support (e.g. compliance, regulatory assessment, and validation) to the business unit, with a particular focus on maintaining the qualified status of equipment and systems during routine operation (autoclaves, fridges, freezers, cleanrooms, sterilization in place among others).
- Writing and implementing qualification documents and procedures required for compliance with pharmaceutical regulations.
- Prepares, reviews and approves production, validation, audit reports documents, procedures, and rationales.
- Evaluates new regulations, changes to existing regulations and regulatory trends; prepares inspections and customer audit responses and reports; performs gap analysis to resolve efficiencies and take appropriate actions.
- Defines, in collaboration with other partners (Quality Assurance, System Owner…) the requalification strategy of GMP systems and implements it, including maintaining the quality system and complete prac...
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