QA Expert

Vor 4 Tagen


Glattbrugg, Schweiz Panda International Vollzeit

Together with our key big pharma client in Neuchatel, we are looking for a Senior QA Expert to act as the key member of their Quality Assurance team, ensuring compliance and quality oversight of manufacturing and release processes for bulk drug substances (BDS). This role combines routine GMP (Good Manufacturing Practices) activities, project involvement, and continuous improvement initiatives. The QA Expert also plays an active role in audits, inspections, and maintaining regulatory compliance.

Key Responsibilities:

  • Oversee compliance during manufacturing and release processes for BDS.
  • Ensure quality and accuracy in documentation and systems, adhering to GMP and regulatory requirements.
  • Support internal and external audits, as well as regulatory inspections.
  • Collaborate on site improvement projects and promote continuous quality improvement.
  • Understand and apply EHS guidelines to ensure safety and compliance.
  • Act as a backup for other QA Experts or the QA Manager/Supervisor as needed.

Qualifications:

  • Strong knowledge of GMP and regulatory frameworks.
  • Experience in quality assurance in a pharmaceutical or biotech setting.
  • Excellent organizational and communication skills.
  • Ability to work collaboratively and lead quality-focused initiatives.

Practicalities:

  • Location: Neuchâtel
  • Duration: 6 months
  • Work Model: Hybrid (3 days on-site, 2 days remote)
  • Languages: English, French preferred
#J-18808-Ljbffr
  • QA Manager

    vor 4 Monaten


    Glattbrugg, Schweiz Coopers Group AG Vollzeit

    **QA Manager** Drive and support analytical method life cycle management (LCM) strategy for in-process, release and stability testing of commercial products **Responsibilities**: - Leads multisite assay transfers via providing assay transfer strategy and project management with internal and external laboratories - Serve as SME for analytical methods...