Quality Specialist Deviations & CAPAs

About UsBesins Healthcare is a global, family-owned pharmaceutical company specializing in the development and manufacturing of medical-grade hormones, with deep expertise in the following areas: gynaecology, fertility, obstetrics, endocrinology, and hormone deficiency treatments.We are fully dedicated to advancing reproductive hormone therapies that support the lifelong health and well-being of women and men.With a strong presence in over 90 countries, supported by 1,500 passionate employees, 22 subsidiaries, and 5 cutting-edge production sites, our continued growth is fueled by innovation, expanding current products into new territories, and partnering for distribution.Job Purpose:The Quality Specialist - Deviations & CAPAs will own the management and improvement of deviation and CAPA processes across all sites and external partners. This role requires prioritization of complex records, strong cross-functional coordination, and active contribution to digital quality transformation initiatives.Deviations & CAPAs ManagementServe as process owner for the deviation and CAPA lifecycle.Prioritize records based on risk, regulatory impact, and business needs.Lead investigations, perform root cause analyses, and ensure timely implementation of corrective and preventive actions.Conduct effectiveness checks and drive continuous improvement initiatives.Harmonize deviation/CAPA processes across our several production sites and external partners, ensuring global consistency.Collaborate with PV, QC, Manufacturing, and other functions to resolve deviations.Track and analyze KPIs and trends, providing actionable management reports.Support audits and inspections as a subject matter expert (SME).Training & GuidanceDevelop and deliver training and guidance on deviation and CAPA processes for site teams, partners, and management.Act as the primary point of contact for deviation/CAPA questions, ensuring clarity and alignment across stakeholders.eQMS & Digital Quality TransformationManage deviation and CAPA records in eQMS, ensuring data integrity and compliance.Support system validation, updates, and workflow optimization.Contribute to digital quality transformation initiatives to improve process efficiency and consistency.Cross-Functional CollaborationCoordinate closely with other Quality Specialists (PV/eQMS, Documentation & Change Control) to ensure alignment and avoid duplication.Work with internal departments and external partners to resolve quality issues efficiently.Analyze multi-departmental records to identify systemic issues and improvement opportunities.Audits & InspectionsAct as SME during internal and external audits/inspections.Ensure deviation and CAPA documentation complies with regulatory and internal standards.RequirementsDegree in Pharmacy, Life Sciences, Engineering, or related field; Master’s in Quality, Regulatory, or scientific field preferred.2+ years in pharmaceutical/biotech industry in quality, regulatory, or manufacturing.Strong knowledge of GMP, GxPs, EU/FDA/ICH regulations.Experience managing deviations and CAPAs in multi-site or outsourced environments.Proficiency in eQMS systems, MS Office, and SharePoint.Excellent communication and interpersonal skills, with the ability to clearly convey complex quality information to global teams, site personnel, and external partners.Able to facilitate cross-functional meetings, provide guidance, and deliver training effectively.Strong organizational, analytical, and project management skills.Fluent in English; additional languages a plus.Interested? Please apply and join us!