QA Auditor Compliance Manager (Contract)

A QA Manager position is open for immediate start in Allschwil, Switzerland, focusing on GMP/GDP quality assurance within the Global Pharmaceutical Development and Quality Assurance business area. This role is crucial for ensuring that all medicinal products are developed, manufactured, and controlled according to the highest quality standards. The position is contract-based until the end of December 2024, with a competitive hourly rate.


Role:

• Provide GMP/GDP quality assurance expertise throughout the development and commercialization stages of the company's products.
• Guide the resolution of quality issues such as complaints, testing anomalies, deviations, and Out of Specifications (OOS) by recommending corrective and preventive actions.
• Manage quality risk using six sigma principles to ensure comprehensive understanding and implementation of quality across all project stages.
• Oversee the release processes for active ingredients, commercial products, and investigational medicinal products, including the review of master documentation and batch records.
• Participate in CMC team meetings, representing and defending quality activities, and notify management of potential quality or regulatory issues.
• Conduct GMP/GDP onsite audits at Contract Manufacturing Organizations (CMOs) as needed and assist in the preparation of GMP/GDP agreements.
• Write, review, and approve internal SOPs and other quality-related documentation.
• Engage proactively in optimizing the pharmaceutical quality system by reviewing CMO performance and suggesting improvements.

Candidate Requirements:

• University degree in Pharmacy, Chemistry, or a related technical/science field at Master's level minimum.
• Strong experience in roles related to pharmaceutical product development, quality control, analytical development, or chemical production.
• Equivalent experience in quality assurance of drug substances and/or drug products.
• Comprehensive understanding of the drug development process, manufacturing, quality control, packaging, and distribution.
• Strong knowledge of current Good Manufacturing Practices (cGMP) and Good Distribution Practices (GDP).
• Capable of interpreting and implementing quality standards and managing complex projects with minimal supervision.
• Effective interpersonal and influencing skills, with the confidence and autonomy to handle complex situations.
• Fluent in English and preferably has basic knowledge of another European language, with German or French being advantageous.

This role offers a unique opportunity to influence the quality assurance processes of a leading pharmaceutical development company. If you meet the qualifications and are looking for a challenging role in a dynamic environment, apply today.