Senior Quality Assurance Specialist - 6548 ADA
Our client is a specialist biotherapeutics manufacturer with over a century of experience treating various diseases worldwide. They are committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases, and other rare diseases.
We are seeking a highly skilled Senior Quality Assurance Specialist for a 12-month contract position at our client's headquarters in Bern. In this role, you will be part of a team responsible for ensuring GMP-compliant processing of deviations, complaints, and complex quality issues, supporting the high-quality standards of products for customers. Fluency in both English & German is mandatory.
Main Responsibilities:
* Support and advise in the field of aseptic production and microbiological laboratories (no implementation of activities within the production or laboratory).
* Checking and ensuring compliance with GMP requirements in production.
* Assumption and collaboration in projects in the field of aseptic production (e.g., involvement in the commissioning of a new filling line, implementation of additional regulatory requirements like Annex 1).
* Control, review, and documentation of work steps, review of processes in aseptic production.
* Participation in the training and (re)qualification of employees in aseptic production.
* Support of production during problems in manufacturing with regard to compliance and risk assessment.
* Supervision of complex deviations in aseptic filling and visual inspection.
* Conducting initial assessments.
* Supporting investigation strategies and technical assessments within investigations.
* Supporting deviation examinations, including defining corrective and preventive measures (CAPAs).
* Reviewing investigation reports in German and English for compliance and risk assessment.
* Preparing and presenting deviations during internal and external inspections.
* Reviewing Specification Documents.
Qualifications & Experience:
* Relevant working/residency permit or Swiss/EU citizenship required.
* A degree in natural sciences (Bachelor's, Master's, or PhD) or comparable qualification.
* At least 3 years of GMP experience, ideally in the pharmaceutical industry.
* Analytical mindset with the ability to understand complex relationships and communicate them clearly.
* Good understanding of report structures and ability to critically question them.
* Team-oriented, with strong communication skills, assertiveness, and the ability to engage at all hierarchical levels.
* Ability to manage multiple projects and adapt to changing circumstances.
* High degree of independence and initiative.
* Proficiency in both German and English, spoken and written.
* Work involves office tasks (approx. 80%) and inspections in cleanrooms (class C/D/E).
* Hybrid role with 2 days home office per week.
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