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Qa qms senior specialist

Saint-Prex
Ferring Holding SA
Inserat online seit: 10 Juni
Beschreibung

Ph3Job Overview /h3pQA QMS Senior Specialist at Ferring Pharmaceuticals. Responsible for implementing, maintaining and continuously improving Quality Management System processes at the site level with a focus on deviations, self‑inspections, QA oversight and inspection readiness. /ph3Responsibilities /h3ulliLead and maintain the Deviation Management System in line with corporate procedures and GMP requirements. /liliOwn and coordinate the self‑inspection program, including annual planning, data analysis, reporting and support to contributors. /liliContribute to Health Authority inspections by leading readiness activities and acting as QMS representative or process expert during inspections. /liliReview and approve quality records, procedures, protocols and reports within the area of expertise. /liliProvide QA oversight for training processes and train new employees on GMP systems and applicable quality processes. /liliSupport regulatory surveillance activities related to Pharmacopoeias, including report review and process improvement. /liliDrive continuous improvement initiatives and support site GxP compliance activities across quality systems. /li /ulh3Qualifications /h3ulliBachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, Biotechnology or a related scientific discipline. /liliProven experience in Quality Assurance and Quality Management Systems within a GMP‑regulated pharmaceutical or biotechnology environment. /liliStrong knowledge of deviation management, self‑inspections, CAPA and inspection readiness activities. /liliExperience drafting, reviewing and approving GMP documentation, procedures, protocols and quality records. /liliAbility to train and support cross‑functional stakeholders on quality systems and compliance expectations. /liliExperience participating in Health Authority inspections and/or supplier audits. /liliStrong analytical skills with the ability to trend data, identify compliance risks and support continuous improvement. /liliExcellent written and spoken English skills, with the ability to draft clear GMP documentation and communicate effectively with cross‑functional and international stakeholders. /liliExperience with Electronic Quality Systems such as TrackWise and Veeva. /liliKnowledge of Pharmacopoeia regulatory surveillance processes. /liliGood knowledge of GMP/GxP requirements, quality systems governance, inspection management, root cause analysis, CAPA processes and quality reporting tools. /li /ulh3Location /h3pSwitzerland, SMP – St. Prex. /ph3EEO Statement /h3pWe strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status. /p /p #J-18808-Ljbffr

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