Regulatory Compliance Specialist

Vor 5 Tagen


Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit
Company Overview

Gi Group SA is a renowned staffing agency that specializes in providing top talent to the pharmaceutical industry. We are committed to delivering exceptional recruitment services and building long-lasting relationships with our clients.

Job Description

We are currently seeking an experienced Quality Assurance Manager to join our client's team in Basel. As a Quality Assurance Manager, you will play a crucial role in ensuring the quality and compliance of our client's products. Your primary responsibilities will include reviewing and approving SOPs, protocols, reports, Certificate of Analysis, and other quality-related documents. You will also be responsible for investigating deviations and out-of-specifications (OOS) issues, maintaining and recording corrective and preventive measures (CAPAs), and acting as a Quality Assurance point of contact for our customers. Additionally, you will organize and manage customer audits and inspections, apply and interpret audit and compliance requirements, and perform internal audits and provide support for GMP training.

Required Skills and Qualifications

To be successful in this role, you will need to possess a scientific education (Master degree) in analytical chemistry, biochemistry, or life sciences. You must be fluent in English and German and have at least 7 years of experience in the analytical-pharmaceutical environment, preferably in Quality Assurance. You should also have profound expertise in the regulatory framework in the GMP environment, including ICH, FDA, USAP, and Ph. Eur. Furthermore, you should have a background in data integrity and computerized systems, risk assessment, and project support. Excellent problem-solving skills and outstanding communication skills are essential for this role.

Benefits

This is a full-time position offering a competitive salary, which we estimate to be around $80,000 - $110,000 per year, depending on your level of experience. The salary includes benefits such as health insurance, retirement plans, and paid time off. If you have gained experience as an auditor, this is considered an asset. Our company culture values teamwork, innovation, and continuous learning, making it an excellent fit for those who thrive in a collaborative environment. In return for your hard work and dedication, you can expect to grow professionally and personally, while enjoying a healthy work-life balance.

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