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Quality Assurance Specialist
vor 1 Woche
Experis Switzerland is the global leader in professional resourcing and project-based workforce solutions.
We are looking for a Quality Assurance Specialist with experience in Drug Product Services to join our team in Visp.
Job Description
The selected candidate will supervise Compliance & Customer quality agreement (QAA) activities for Drug Product Visp, establish and negotiate Quality Agreements (QAA) with external partners, and act as point of contact for Drug Product QA related questions, topics, and complaints from customers.
Responsibilities:
- 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.
- Author, review, and approve GMP-relevant documents and SOPs.
- Support continuous improvement programs to establish an effective Quality Management System for Drug Product.
