Qualification Validation Manager 24008

vor 3 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.

  • Qualification Expert

    vor 2 Wochen

    Kaiseraugst, Schweiz ITech Consult Vollzeit

    **Qualification Expert (M/F/d)** **Qualification Expert (M/F/d) - GMP /** **COMOS / EVAL / German / English** **Project**: For our customer a big pharmaceutical company based in Kaiseraugst we are looking for a highly qualified Qualification Expert (M/F/d) **Background**: The support function ES&T (Engineering, Science and Technology) supports the value...

  • Qualification Expert

    vor 2 Wochen

    Kaiseraugst, Aargau, Schweiz ITech Consult Vollzeit

    Qualification Expert (M/F/d)Qualification Expert (M/F/d) - GMP / COMOS / EVAL / German / EnglishProject:For our customer a big pharmaceutical company based in Kaiseraugst we are looking for a highly qualified Qualification Expert (M/F/d)Background:The support function ES&T (Engineering, Science and Technology) supports the value streams (production) with its...

  • Qualification Expert

    vor 11 Stunden

    Kaiseraugst, Schweiz ELAN Personal AG Vollzeit

    Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Kaiseraugst, we are looking for aQualification Expert (m/f/d)Background:The support function ES&T (Engineering, Science and Technology) supports the value streams...

  • Qualification Expert

    Vor 5 Tagen

    Kaiseraugst, Schweiz Work Selection Vollzeit

    We are looking for a motivated and committed Qualification Expert for our client, F. Hoffmann-La Roche Ltd. based in Kaiseraugst, for a 12 month assignment with the option to extend.The support function ES&T (Engineering, Science and Technology) supports the value streams (production) with its technical expertise and ensures the regulatory requirements for...

  • Qualification Expert, Kaiseraugst

    vor 2 Wochen

    Kaiseraugst, Aargau, Schweiz Roche Vollzeit

    The Position With its 1,400 employees, the Kaiseraugst production center (PT Manufacturing) ensures uninterrupted patient care with high-quality medicines. We stand for the highest standards of pharmaceutical manufacturing, Roche's largest, most innovative packaging center and serving more than 120 countries. For a successful production site Kaiseraugst...

  • Qualification Expert, Kaiseraugst

    vor 2 Monaten

    Kaiseraugst, Schweiz Roche Vollzeit

    The Position With its 1,400 employees, the Kaiseraugst production center (PT Manufacturing) ensures uninterrupted patient care with high-quality medicines. We stand for the highest standards of pharmaceutical manufacturing, Roche's largest, most innovative packaging center and serving more than 120 countries. For a successful production site...

  • Qualification Expert, Kaiseraugst

    vor 4 Wochen

    Kaiseraugst, Schweiz Roche Vollzeit

    The Position With its 1,400 employees, the Kaiseraugst production center (PT Manufacturing) ensures uninterrupted patient care with high-quality medicines. We stand for the highest standards of pharmaceutical manufacturing, Roche's largest, most innovative packaging center and serving more than 120 countries. For a successful production site...

  • Suppliers Quality Manager

    vor 4 Wochen

    Kaiseraugst, Schweiz DSM Vollzeit

    **City, Country**:Kaiseraugst **Hybrid/Remote/On Site/**:Hybrid The Quality Manager VS-P&B acts as the quality link between the supplier/producer and dsm-firmenich. Internally, the Quality Manager VS-P&B works closely together with Product Regulatory and Quality Managers, Category and Product management, Purchasing, Supply Chain Managers, Customer Support...

  • Quality Manager

    vor 3 Monaten

    Kaiseraugst, Schweiz Manpower Vollzeit

    For our client, an internationally renowned company which produces intermediate and/or end products such as vitamins, pharmaceuticals, substances for the cosmetics industry, carotenoids, folic acid and many other high-quality products, we are looking for you as a **Your mission** - Supplier/producer/material (re-)qualification in coordination with...

  • Suppliers Quality Manager

    vor 2 Wochen

    Kaiseraugst, Aargau, Schweiz DSM Vollzeit

    City, Country:KaiseraugstHybrid/Remote/On Site/:HybridThe Quality Manager VS-P&B acts as the quality link between the supplier/producer and dsm-firmenich. Internally, the Quality Manager VS-P&B works closely together with Product Regulatory and Quality Managers, Category and Product management, Purchasing, Supply Chain Managers, Customer Support teams and...

  • Suppliers Quality Manager

    vor 4 Wochen

    Kaiseraugst, Aargau, Schweiz dsm-firmenich Vollzeit

    City, Country: Kaiseraugst Hybrid/Remote/On Site/: Hybrid This is a unique opportunity to work in the Virtual Site (VS) - Perfumery & Beauty (P&B) team which is responsible for quality management of Strategically Sourced Products (SSP). The current P&B SPP portfolio consists of Personal Care ingredients and includes around 85 products from 30 suppliers, and...

  • Suppliers Quality Manager

    vor 2 Wochen

    Kaiseraugst, Aargau, Schweiz DSM Vollzeit

    City, Country: Kaiseraugst Hybrid/Remote/On Site/: Hybrid This is a unique opportunity to work in the Virtual Site (VS) - Perfumery & Beauty (P&B) team which is responsible for quality management of Strategically Sourced Products (SSP). The current P&B SPP portfolio consists of Personal Care ingredients and includes around 85 products from 30...

  • Suppliers Quality Manager

    vor 2 Wochen

    Kaiseraugst, Aargau, Schweiz dsm-firmenich Vollzeit

    City, Country: Kaiseraugst Hybrid/Remote/On Site/: Hybrid This is a unique opportunity to work in the Virtual Site (VS) - Perfumery & Beauty (P&B) team which is responsible for quality management of Strategically Sourced Products (SSP). The current P&B SPP portfolio consists of Personal Care ingredients and includes around 85 products from 30 suppliers, and...

  • Suppliers Quality Manager

    vor 4 Wochen

    Kaiseraugst, Aargau, Schweiz dsm-firmenich Vollzeit

    City, Country: Kaiseraugst Hybrid/Remote/On Site/: Hybrid This is a unique opportunity to work in the Virtual Site (VS) - Perfumery & Beauty (P&B) team which is responsible for quality management of Strategically Sourced Products (SSP). The current P&B SPP portfolio consists of Personal Care ingredients and includes around 85 products from 30 suppliers, and...

  • Suppliers Quality Manager

    vor 4 Wochen

    Kaiseraugst, Schweiz DSM Vollzeit

    City, Country: Kaiseraugst  Hybrid/Remote/On Site/: Hybrid  This is a unique opportunity to work in the Virtual Site (VS) - Perfumery & Beauty (P&B) team which is responsible for quality management of Strategically Sourced Products (SSP). The current P&B SPP portfolio consists of Personal Care ingredients and includes around 85 products from 30...

  • Suppliers Quality Manager

    vor 4 Wochen

    Kaiseraugst, Schweiz dsm-firmenich Vollzeit

    City, Country: Kaiseraugst Hybrid/Remote/On Site/: Hybrid This is a unique opportunity to work in the Virtual Site (VS) - Perfumery & Beauty (P&B) team which is responsible for quality management of Strategically Sourced Products (SSP). The current P&B SPP portfolio consists of Personal Care ingredients and includes around 85 products from 30 suppliers,...

  • Suppliers Quality Manager

    vor 4 Wochen

    Kaiseraugst, Schweiz dsm-firmenich Vollzeit

    City, Country: Kaiseraugst Hybrid/Remote/On Site/: Hybrid This is a unique opportunity to work in the Virtual Site (VS) - Perfumery & Beauty (P&B) team which is responsible for quality management of Strategically Sourced Products (SSP). The current P&B SPP portfolio consists of Personal Care ingredients and includes around 85 products from 30 suppliers,...

  • Reviewer and Technical Author 80% 23054

    vor 4 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...

  • Reviewer and Technical Author 80% 23054

    vor 4 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,...

  • Inside Account Manager

    vor 2 Wochen

    Kaiseraugst, Aargau, 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, about...