GMP Professional

Vor 6 Tagen


Basel, Basel-Stadt, Schweiz Actalent Vollzeit

Seeking a highly skilled GMP Professional to join our team and drive excellence in quality assurance. In this role, you will be responsible for ensuring the compliance and continuous improvement of GMP standards across all IMP production facilities.

About the Role:

The Synthetic Molecules IMP Quality Group is responsible for quality oversight of the Synthetic Molecules Drug Substance and Drug Product operations, as well as the associated QC control. As a GMP Professional, you will play a critical role in conducting thorough reviews and approvals of analytical methods, method validations, specifications, risk assessments, deviation reports, investigations, change control records, and stability reports to ensure compliance with GMP standards.

Responsibilities:
  • Develop and maintain product-related quality agreements to ensure clear and consistent quality expectations and standards.
  • Conduct thorough reviews and approvals of analytical methods, method validations, specifications, risk assessments, deviation reports, investigations, change control records, and stability reports to ensure compliance with GMP standards.
  • Provide expert support to departments on GMP-related issues, offering guidance and solutions to ensure compliance and continuous improvement.
  • Plan and execute self-inspections to identify areas for improvement and ensure adherence to GMP standards.
  • Monitor and oversee the quality control processes for Synthetic Molecules Drug Substance and Drug Product operations, ensuring all activities meet regulatory requirements.
Requirements:
  • At least 5 years of experience in the pharmaceutical industry.
  • Ideal professional experience in pharmaceutical development (Synthetic Molecules, Quality Control, or Quality Assurance).
  • Knowledge of cGMP and quality requirements, ideally for clinical development phases.
  • Good IT skills (MS Office) - especially experience with SAP and other quality management systems (e.g., Veeva).
  • Excellent communication and teamwork skills.
  • Independent working style, high quality awareness.
  • Fluent in German and English, both written and spoken.


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