QA Specialist and Batch Record Reviewer (5485)

The Life Science Career Network

CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.

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:

QA Specialist and Batch Record Reviewer

for a contract until the end of the year, based in the Valais area, Switzerland.

Main Responsibilities:

• Verifying the company's compliance with ISO/cGMP quality system requirements;
• Providing support to operations and quality control staff to address compliance related concerns;
• Auditing internal quality system elements in manufacturing and operational support areas;
• Providing oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations;
• Independently identifying and managing special projects or QA compliance functions;
• Reviewing and approving validation documents, e.g. Review Master Batch Records (MBR);
• Performing review and release of batch records.

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required;
• At least 1 year of experience in a similar role;
• Commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing environment;
• GMP compliance and Part 11 compliance knowledge preferred;
• Experience with oversight of aseptic processing and the associated international aseptic processing regulations.

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us.