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QA PL Drug Product Expert
vor 1 Woche
Join Experis Switzerland as a QA PL Drug Product Expert and take on a challenging role in our team in Visp.
Role Overview
The selected candidate will be responsible for supervising compliance and customer quality agreements (QAA) activities for Drug Product Visp, establishing and negotiating quality agreements (QAA) with external partners, and acting as point of contact for Drug Product QA related questions, topics, and complaints from customers.
Main Tasks:
- Supervise compliance and customer quality agreements (QAA) activities for Drug Product Visp.
- Establish and negotiate quality agreements (QAA) with external partners.
- Act as point of contact for Drug Product QA related questions, topics, and complaints from customers.
- Represent Quality Assurance in cross-functional teams, establish and maintain interfaces with manufacturing teams, QC, support functions, and project/site engineering projects/technology transfer to effectively execute tasks related to Drug Product processes.
- Support and approve project/product specific risk assessments or regulatory specific risk or gap assessments.
- Review and release product specific documentation such as process descriptions, recipes, manufacturing protocols, transfer documents, test plans, parameter lists, etc.
- Work closely with QC-Project Leader (QC-PL) and MSAT for New-Product-Introductions (NPI).
- Assess, review, and approve quality records e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions in line with current local SOPs.
