Our client, headquartered in Baar, is dedicated to cancer research, developing advanced diagnostics and therapies to improve patient outcomes.
To support their growing team, we are looking for a versatile and motivated QA Specialist and Deputy RP (FvP/QP) to help shape a new and dynamic laboratory environment focused on quality control of generics and nutritional supplements.
In this role, you will play a key part in ensuring regulatory compliance and product quality across several Swiss legal entities.
If you're passionate about software quality, regulatory compliance, and delivering impactful solutions in the life sciences industry, this could be the ideal opportunity for you.
Key Responsibilities include:
* Acting as Deputy QP (FvP), including batch disposition, recalls, and ensuring GDP-compliant
* distribution
* Leading and maintaining the local Quality Management System (QMS) in line with GMP/GDP standards
* Monitoring Out-of-Specification results, deviations, complaints etc.
* Management and scheduling of training
* Conducting management reviews, support with self-inspections, and review of qualification and validation activities on behalf of the RP
* Reviewing analytical methods, specifications, method transfers, method validation, etc. on behalf of the RP
* Assisting and supporting the laboratory team in handling deviations, OOS-results, external complaints and investigations
* Assisting in the laboratory team in setting, changing and approval of product specifications
* Support the Responsible Person with the organization of customer audits and inspections by the authorities
Your Qualifications:
* BSc or MSc in Pharmacy, Chemistry, Biotechnology, or a related field
* Knowledge of Swiss Therapeutic Product Acts and GMP/GDP guidelines
* Several years of experience in GMP/GDP and initial experience in quality assurance within a chemical / pharmaceutical environment
* Validation expertise particularly in the field of equipment qualification, CSV and validation of analytical methods
* Structured and independent personality with a precise and reliable way of working
* Strong analytical mindset with the ability to manage risks, resolve issues, and drive continuous improvement
* Culturally sensitive, enjoy working in international teams and ability to work collaboratively in cross-functional teams
* Excellent communication skills, both written and verbal in English and German
Your Application
Please apply online. For further information about the position, feel free to contact your Gi consultant: Marta Castellano, MSc Biochemistry (marta.castellano@gigroup.com; +41 76 342 57 90).
Branche: Pharma-Industrie
Funktion: Qualitätsprüfung
Führungsperson: Nein
Anstellungsart: Festanstellung
Karrierestufe: Angestellte/r