Quality Systems Analyst – Pharmaceutical Manufacturing

About the role

Helsinn Birex Pharmaceuticals is seeking a Quality Systems Analyst to join its Quality Systems team. The role ensures compliance with cGMP standards, supports audit readiness, and drives continuous improvement across the manufacturing site.

Key responsibilities

• Manage and support Change Control and CAPA processes, ensuring timely and compliant closure with cross‑functional teams.
• Investigate and document customer complaints, providing appropriate responses.
• Schedule and conduct internal audits, identify system gaps and assist in corrective actions.
• Support external audits by partners and regulatory authorities, handling document retrieval and presentation.
• Review and update site documentation such as SOPs, logbooks and forms to meet regulatory requirements.
• Collaborate with vendors to investigate non‑conformances and assess impact on products and processes.
• Prepare and submit Product Quality Reviews and annual KPI reports.
• Contribute to deviation investigations and maintain related databases and logbooks.

Required profile

• Third‑level degree in a life‑science discipline.
• Minimum three years of experience in pharmaceutical solid‑dosage or topical gel manufacturing.
• Experience with quality system processes including deviations, OOS investigations and QA KPIs.
• Proven ability to evaluate analytical data and produce clear technical reports.

Required skills

• cGMP compliance knowledge.
• CAPA and Change Control management.
• Internal and external audit coordination.
• SOP creation and documentation.
• Product Quality Review preparation.