QA Expert Senior

Vor 2 Tagen


Neuenburg, Schweiz TN Switzerland Vollzeit

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Proclinical is seeking a dedicated QA Expert Senior to join the Quality Assurance team. This role focuses on ensuring compliance and quality oversight during the manufacturing and release process of bulk drug substances. You will play a key role in maintaining high standards of quality and regulatory compliance.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

  • Oversee compliance and quality during the manufacturing and release process of bulk drug substances.
  • Represent the QA department in routine GMP activities and improvement projects.
  • Ensure accurate reporting within various systems and documentation in line with current guidelines and regulatory requirements.
  • Participate in GMP zone audits and internal/external regulatory inspections.
  • Promote continuous improvement initiatives.
  • Understand and apply EHS guidelines, ensuring personal safety and reporting risks or improvement opportunities.
  • Act as a backup for other QA Experts and QA Manager/Supervisor as needed.

Key Skills and Requirements:

  • Strong understanding of GMP and regulatory compliance.
  • Experience in quality assurance within a manufacturing environment.
  • Ability to participate in audits and inspections.
  • Commitment to continuous improvement and safety standards.
  • Excellent communication and documentation skills.
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