QA Specialist (5288)

Quality Assurance Specialist – 5288 (ADA)

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a Quality Assurance Specialist based in the Valais area of Switzerland.

This is a contract role for 6 months starting as soon as possible. There is a requirement of 2 FTEs for this position.

Main Responsibilities:

·      QA project management, ensuring of the company's compliance with cGMP quality system.

·      Provide immediate support to operations and quality control staff to address compliance related concerns (QA "on-the-floor" support).

·      Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams.

·      Provide oversight for compliance of Change Controls, CAPA and investigations, OOS and deviations.

·      Review and approve electronic Master Batch Records (eMBR) and supporting documents.

·      Perform review/release of batch records, as needed.

Qualifications and Experience:

·      Relevant working/residency permit or Swiss/EU-Citizenship required.

·      Direct QA drug substance production experience required.

·      GMP compliance knowledge required.

·      Excellent written and oral communication in English to include accurate and legible documentation skills.

·      Ability to work in a fast-paced environment.

·      Team oriented, independent work skills and a strong work ethic.

·      The ability to interface and communicate directly with clients is required.

·      Microsoft Office, TrackWise and LIMS skills, organization skills, record keeping skills and ability to handle multiple projects.

·      1-3 Years of Experience in QA is required