Qualification Validation Manager 24008

vor 2 Wochen

Kaiseraugst, Schweiz Solvias AG Vollzeit

**Company information**
Solvias is an internationally recognized provider of integrated solutions in contract analytical research, development and manufacturing. The company offers a broad spectrum of services and solutions in the Pharmaceutical, Biotech, Medical Device, Cell&Gene Therapy and Cosmetic industries. With headquarters near Basel, Switzerland, over 800 highly qualified employees take pride in putting science at the heart of serving customers to bring safer and better products to market faster.

Be part of your challenge: take a big jump and do the change of your life

Job Description
- Executes establishment and maintenance of Equipment Qualification System for the Operations
- Ensures proper qualification of equipment/instruments/computerized-systems and method validation/transfer/qualification/verification by guaranteeing adherence to the corresponding regulation requirements
- Acts as first contact for equipment qualification & maintenance within QA as well as equipment qualification document life cycle management and compliance issues for equipment qualification in shared systems (e.g. LIMS, CDS,)
- Supervises and executes compliance activities including but not limited to releasing method validation/transfer/qualification/verification documents and to assigning GMP status and trending of equipment qualification/re-qualification in relation to supplier qualification, changes, CAPAs, audit observations, vendor change notification
- Takes care of proper qualification of GMP staff by supervising adherence to GMP trainings as well as of equipment supplier /services by supervising adherence to quality agreements
- Advises on preparation of service agreements, URS, DQ and qualification documents
- Keeps track of GMP status of equipment/instruments/ computerized systems
- Support deviations management and continuous process improvement in the area of responsibility

Requirements
- 4 years working experience in pharmaceutical industries and GMP controlled environment preferable in Quality Control, Production or Quality Assurance.
- Very good working knowledge in EU and US GMP regulations relevant for equipment qualification, maintenance, method validation/transfer and corresponding compliance systems
- Solid know-how in EU and US GMP regulations relevant for computerized systems validation
- Advanced knowledge in Data Integrity rules and requirements
- Excellent communication and decision making skills
- Ability to provide solutions for complex challenges and work independently in a team environment
- Solution oriented, precise, and organized
- Good inter-personal skills
- Energized and open-minded
- Willingness to learn and carry out new and complex tasks
- Proactive attitude
- Excellent in German and English, French is a plus

**What we currently offer**:
Our employees are very close to our hearts. At Solvias, you get:

- a well-structured onboarding program
- intensive training in the beginning
- the possibility for further development

Furthermore, there are a multiple range of benefits like:

- flexible working time models
- 40 hours week
- at least 28.5 vacation days per year (depending on your age)
- commuter contribution for using public transport
- contribution to German and English language courses
- staff restaurant

This job offer is a challenging opportunity in a company that values respect, responsibility, and reliability. At Solvias everyone counts and contributes to the success of the company. We strive to create an environment where we learn from each other and are open to feedback.

**We do not consider Headhunters / Agencies for this position.

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