Lead QA Scientist for Pharmaceutical Operations

vor 13 Stunden


Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

Gi Group SA is a leading provider of innovative solutions for the pharmaceutical industry. We are seeking a highly skilled and experienced Lead QA Scientist to join our team in this key role.

Job Summary

As a Lead QA Scientist, you will be responsible for implementing quality processes and ensuring compliance with regulatory requirements. Your expertise in pharmaceutical manufacturing processes, particularly in biologic drug substance, will be essential in driving continuous improvement initiatives and maintaining high-quality standards.

Key Responsibilities
  • Quality Management: Develop and implement quality procedures and protocols to ensure adherence to cGMP rules, Quality policies, and instructions.

  • Process Improvement: Collaborate with cross-functional teams to identify areas for improvement and implement changes to optimize quality processes and reduce deviations.

  • Regulatory Compliance: Ensure compliance with regulatory requirements and industry standards, including SOPs and training programs.

  • Documentation and Training: Develop and maintain accurate and up-to-date documentation, including procedure manuals and training materials.

  • Leadership and Communication: Provide guidance and support to junior team members, facilitate communication across departments, and contribute to a positive and inclusive work environment.

Requirements

To succeed as a Lead QA Scientist, you will need:

  • Pharmacist, Chemist / Biologist / Microbiologist / Biochemist or Immunolgist degree with a master's degree or higher.

  • 3-5 years of experience in the pharmaceutical industry, preferably in commercial batch release.

  • Fluent communication skills in German and English (oral and written).

  • Experience with SAP and electronic MES is an asset.

If you have a passion for quality assurance and a strong background in pharmaceutical operations, we encourage you to apply for this exciting opportunity.



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