Leading GMP Compliance Specialist

vor 1 Tag


Marly Fribourg, Schweiz InnoMedica Vollzeit

As a key member of our Quality Assurance team at InnoMedica, you will play a pivotal role in maintaining and expanding our pharmaceutical quality system, ensuring compliance with Swiss and European Good Manufacturing Practice (GMP) guidelines.

Your responsibilities will include:

GMP Documentation Management

• Oversight of GMP documentation to guarantee adherence to national and international standards.

Team Leadership

• Leadership of a small team, providing guidance and support to ensure seamless execution of tasks.

Audit and Inspection Responsibilities

• Accountability for internal audits and inspections by regulatory authorities.

Batch Documentation Preparation

• Preparation of batch documentation for certification by the responsible person for clinical trials.

Core Quality Assurance Tasks

• Participation in core quality assurance activities, including writing and reviewing deviations, CAPAs, change requests, SOPs, qualifications, and validations.

Interdepartmental Collaboration

• Active involvement in interdepartmental project teams, driving collaboration between process engineering, production, and quality control departments.

To excel in this challenging role, we require a university degree in a relevant field (e.g., biochemistry, chemistry, pharmacy). A minimum of 5 years of practical experience in a GMP environment is essential. Excellent interpersonal skills, leadership abilities, and analytical thinking are also crucial. You should be able to maintain a clear overview even in fast-paced situations, demonstrate initiative, and embody an entrepreneurial spirit. Fluency in English is mandatory; knowledge of German or French is beneficial.

We estimate the annual salary for this position to be around $85,000-$110,000, depending on your qualifications and experience. If you're passionate about working in a dynamic start-up environment and contributing to the success of our company, we encourage you to apply.



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