Helsinn Birex Pharmaceuticals is currently seeking a Quality Systems Analyst to join our Quality Systems team. This role is responsible for maintaining, promoting, and ensuring compliance with Quality Systems in accordance with cGMP. The successful candidate will also support audit readiness and execution across the site, contributing to continuous improvement and regulatory compliance.Key ResponsibilitiesManage and support the Change Control and CAPA processes, ensuring timely and compliant closure in collaboration with cross-functional departments.Investigate and document customer complaints according to company procedures, ensuring appropriate and timely responses.Schedule and perform internal audits, identify quality system gaps, and assist departments in implementing effective corrective actions.Support external audits by partners and regulatory authorities, including document retrieval, preparation, and presentation.Review and update site documentation (e.g., SOPs, logbooks, forms) to ensure compliance with site, corporate, and regulatory requirements.Collaborate with vendors to investigate non-conformances and assess impact on HBP products and processes.Prepare and submit Product Quality Reviews and annual reports on key Quality System KPIs.Contribute to deviation investigations as needed and maintain related databases and logbooks.Ensure all Quality Systems SOPs are accurate and reflect current regulatory expectations.Required Qualifications and ExperienceA third-level degree in a life science discipline.Minimum of 3 years’ experience working within a pharmaceutical manufacturing solid dosage or pharmaceutical topical gel manufacturing environment.Demonstrated experience with Quality Systems processes such as deviations, OOS investigations, and QA KPIs.Proven ability to critically evaluate analytical data and author clear, professional technical reports.Strong attention to detail and organizational skills.Proactive and methodical approach to problem-solving.Excellent communication and interpersonal skills.Ability to work collaboratively across departments and with external stakeholders.Strong knowledge of GMP standards and regulatory compliance.
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