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Qa qms senior specialist

Saint-Prex
Ferring Holding SA
Inserat online seit: 9 Juni
Beschreibung

Job Overview

QA 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.


Responsibilities

* Lead and maintain the Deviation Management System in line with corporate procedures and GMP requirements.
* Own and coordinate the self‑inspection program, including annual planning, data analysis, reporting and support to contributors.
* Contribute to Health Authority inspections by leading readiness activities and acting as QMS representative or process expert during inspections.
* Review and approve quality records, procedures, protocols and reports within the area of expertise.
* Provide QA oversight for training processes and train new employees on GMP systems and applicable quality processes.
* Support regulatory surveillance activities related to Pharmacopoeias, including report review and process improvement.
* Drive continuous improvement initiatives and support site GxP compliance activities across quality systems.


Qualifications

* Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Chemistry, Biotechnology or a related scientific discipline.
* Proven experience in Quality Assurance and Quality Management Systems within a GMP‑regulated pharmaceutical or biotechnology environment.
* Strong knowledge of deviation management, self‑inspections, CAPA and inspection readiness activities.
* Experience drafting, reviewing and approving GMP documentation, procedures, protocols and quality records.
* Ability to train and support cross‑functional stakeholders on quality systems and compliance expectations.
* Experience participating in Health Authority inspections and/or supplier audits.
* Strong analytical skills with the ability to trend data, identify compliance risks and support continuous improvement.
* Excellent written and spoken English skills, with the ability to draft clear GMP documentation and communicate effectively with cross‑functional and international stakeholders.
* Experience with Electronic Quality Systems such as TrackWise and Veeva.
* Knowledge of Pharmacopoeia regulatory surveillance processes.
* Good knowledge of GMP/GxP requirements, quality systems governance, inspection management, root cause analysis, CAPA processes and quality reporting tools.


Location

Switzerland, SMP – St. Prex.


EEO Statement

We 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.

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