Senior QA Expert

Panda International; Stein; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Panda International in Stein, Switzerland, seeks a QA professional to oversee QC microbiology, ensuring GMP compliance and timely delivery of project goals. You will review and release batch-related microbiology documents and support cross-functional teams.

The role requires 8+ years in lab execution systems projects, strong cGMP knowledge, experience with health authorities, and fluency in English (German desirable). You will manage KPIs, audits, and SOP ownership.

Qualifikationen

• 8 years+ experience in projects implementing laboratory execution systems in a quality-focused environment.
• Strong background in cGMP regulations (US, European, Japanese Pharmacopoeia).
• Experience interacting with health authorities (FDA, Swissmedic, etc.).
• Fluent in English; German language skills are a plus.

Aufgaben

• Collaborate with cross-functional teams to meet site quality objectives and timelines.
• Provide guidance and quality oversight for QC activities.
• Lead the implementation of gLIMS (laboratory execution system).
• Review and approve GMP-relevant documents and SOPs; manage changes and document control.
• Supervise GMP compliance activities like changes (CRs) and non-conformities (DRs).
• Write or revise SOPs and own these documents.
• Manage KPIs and conduct inspections and audits as required.

Kenntnisse

GMP compliance

Quality assurance

Project management

Regulatory knowledge

Audit & inspection

English fluency

German language

Tools

Laboratory execution systems (LIMS)

Jobbeschreibung

QA responsible for QC microbiology oversight to support departmental projects and objectives according to agreed timelines. Ensures adherence to standards and compliance with GMP regulation in DPS Stein. Review, approve and release of all batch-related microbiology documents

Key Responsibilities

• Collaborate closely with cross-functional teams to work on growth projects as per site quality objectives and strategic goals. Ensure that project timelines and deliverables under the responsibility of QA/QC are fulfilled.
• Provides guidance and quality oversight for QC
• Support growth projects and act as primary point of contact in QA for implementation of gLIMS (laboratory execution system)
• Represents the QA support and guidance to the Quality Control (QC) department and ensures that GMP requirements are met and SOPs are followed.
• Review and Approval of GMP relevant documents from quality control, including SOPs with focus on implementation of gLIMS.
• Supervise and execute GMP compliance activities like changes (CRs), document management, non-conformities (DRs)
• Write or revise SOPs in the area of expertise and be the owner of these documents.
• Support QA for QC raw data review, as deemed required
• Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory GMP guidelines, health authority guidance, SOPs, HSE, etc.)
• Management and reporting of KPIs
• Perform/support inspections and audits as required.
• Performs other duties as assigned
• 8 years + experience in projects in implementation of laboratory execution systems, within a quality-focused environment.
• Strong background in cGMP regulations, including US, European and Japanese Pharmacopoeia.
• Very good knowledge in laboratories/laboratory equipment/software qualification/validation.
• Experience in interaction with health authorities (FDA, Swissmedic, etc.).
• Structured, focused and well-organized working attitude.
• Open-minded for new ideas and suggestions, agile, highly motivated and dynamic drive.
• Pragmatic and solution-orientated mindset.
• Fluent in English, German language is nice to have
• Project management certification would be considered as advantage (Green/Black Belt etc)