QA Expert

Vor 4 Tagen

Neuenburg, Schweiz Proclinical Group Vollzeit

Proclinical is seeking a dedicated Quality Assurance Senior Expert to focus on routine GMP operations in the Fill and Finishing area. This role will be crucial in ensuring compliance with current guidelines and regulatory requirements, with a strong emphasis on maintaining the quality of information within various systems and documentation.

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:
  1. Review production event deviations within quality systems to ensure compliance with standard procedures and regulatory requirements.
  2. Conduct or approve investigations, impact assessments, and define relevant CAPA.
  3. Prepare, evaluate, and approve revisions or creation of controlled documentation.
  4. Attend relevant meetings to support task execution.
  5. Adhere to the escalation process.
  6. Complete necessary training and manage software access in line with company policies.
  7. Occasionally support the team with conventional quality oversight tasks, such as continuous improvement initiatives and GMP tours.
Key Skills and Requirements:
  1. Technical and scientific academic background.
  2. Operational experience in cGMP within a Quality Ops department for sterile injectable pharmaceutical production.
  3. Comprehensive understanding of production processes, including cell culture and aseptic distribution.
  4. Knowledge of Quality standards (cGMP) and Quality Systems (Deviations, CAPA, Change Control, Training, Documentation).
  5. Proficient in document writing in French and/or English.
  6. Fluent in French and English.
  7. Proficient in Microsoft Office and PC work.
  8. Strong teamwork skills, agility, and autonomy.
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