We are seeking a dedicated Quality Assurance Project Manager that will be responsible for supporting continuous improvement programs and establishing an effective Quality Management System. The ideal candidate will represent QA in cross-functional teams and maintain interfaces with various departments to ensure the successful execution of tasks related to Drug Product processes.

Responsibilities:

• Support continuous improvement programs to establish an effective Quality Management System.
• Represent QA in cross-functional teams, interfacing with Manufacturing, QC, Support Functions, Project, and Site Engineering.
• 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.
• Present Drug Product QA topics during customer audits and regulatory inspections.
• Participate in internal audits as required.
• Organize and manage monthly Quality Council & Risk Register.
• Track key Quality indicators monthly in QA staff meetings and update Quality-related KPIs.
• Conduct gap assessments for HA/Audit observations at other facilities.

Project-Specific QA Functions within Drug Product:

• Act as the point of contact for Drug Product QA-related questions and issues related to manufacturing operations.
• Support and approve project/product-specific risk assessments.
• Review and release product-specific documentation (e.g., process descriptions, workflows, recipes, manufacturing protocols, transfer documents, test plans, parameter lists).
• Review and approve executive batch records and prepare batch release for the responsible person (FvP), including recommendations on disposition status.

QA Responsibilities for Customer Contact:

• Manage customer interactions regarding QA topics, including changes, deviations, technical complaints, out-of-specification results, and other issues.

Must-Haves:

• Proven experience in Quality Assurance within the pharmaceutical industry.
• Strong understanding of GMP regulations and SOPs.
• Excellent communication and presentation skills.
• Ability to work effectively in cross-functional teams.
• Experience with quality records management and audit participation.
• Proficiency in tracking and reporting key Quality indicators.
• Ability to manage customer interactions and support project-specific QA functions.

Work Location: Visp

Schedule: 100%

Start Date: 1st of June

Duration: until the end of the year

If you want to learn more about this opportunity please feel free to reach out directly to [email protected]

*While we appreciate every application, please note that due to the high volume of responses, we may only be able to contact shortlisted candidates.