GMP Training & Qualification Lead — Sterile Pharma

Ophtapharm, a Sentiss Company; Zürich; On-site; CHF 150,000 - 210,000; Full time

Job summary

Ophtapharm AG, located near Winterthur, Switzerland, seeks a seasoned GMP training and qualification leader to design and implement the site-wide framework ensuring compliance and inspection readiness.

You will collaborate with Production, Quality, QC, Microbiology and Engineering to modernize training, manage competency, and drive data integrity, safeguarding sterility and patient safety.

Qualifications

• Degree in Pharmacy or related science.
• Several years in GMP-regulated pharma manufacturing.
• Experience in training, qualification, or GMP quality systems.
• Knowledge of FDA, EU GMP, and Annex 1.
• Experience with LMS/eQMS systems.

Responsibilities

• Own and evolve site-wide GMP training and qualification framework.
• Define qualification standards and requalification programs.
• Develop risk-based training curricula and competency assessments.
• Drive modernization and digitalization of training processes and LMS.
• Act as site expert for GMP training and qualification.
• Support audits and quality improvement through training data integrity.
• Foster a culture of competency and continuous learning.

Skills

GMP knowledge

Training & qualification management

Stakeholder engagement

Quality systems familiarity

English & German communication

Education

Degree in Pharmacy or related scientific discipline

Tools

LMS

eQMS

Job description

Ophtapharm AG, located near Winterthur, Switzerland, seeks a seasoned GMP training and qualification leader to design and implement the site-wide framework ensuring compliance and inspection readiness.

You will collaborate with Production, Quality, QC, Microbiology and Engineering to modernize training, manage competency, and drive data integrity, safeguarding sterility and patient safety.