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.
· 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