Senior Quality Engineer (w/m)-00000R27
Description
Cilag AG, being part of the Janssen Supply Chain and a member of Johnson & Johnson Family of companies, is currently looking for a
Senior Quality Engineer (w/m)
to be based in Schaffhausen, Switzerland.
POSITION SUMMARY:
As a Senior Quality Engineer you will be responsible for the quality assurance of site equipment and facilities qualification in the business units of Pharma, Chemical and Medical Devices operations, Utilities and Information Technology.
You will be the Quality Engineering representative on cross functional teams to develop and deliver projects required to achieve company & departmental goals, as well as the site representative in the key compliance areas for the Janssen Supply Chain.
PRINCIPAL RESPONSIBILITIES:
- Evaluation, optimisation and implementation of the qualification system for Cilag AG, Schaffhausen facility in compliance to the current worldwide regulatory requirements
- Advise qualification/validation aspects in Pharma & Chemical operations, Medical Devices, Utilities and Computer System Validation, with the aim that integrated cGMP documentation shall be produced being compliant with relevant regulatory requirements.
- Assure that such documentation is efficiently produced and supports the on-going development and use of those systems
- Maintain the qualified status of automated and non-automated equipment through appropriate change impact assessments as SME (Subject Matter Expert) for CoC’s
- Cooperation in ad-hoc working groups, quality teams, task forces, representing QA Engineering
- Assessment and approval of SOPs, plans and reports in the task field
- Planning and reporting of the qualification status of cGMP critical systems
- Preparation and active participation as spokesperson in internal and external inspections in the framework of Quality Engineering
Qualifications
- University/Master Degree in natural science or technical degree
- At least 5+ years of experience in qualification/ validation with a proven track record in the regulated environment
- Comprehensive background of Pharmaceuticals and Devices regulations and related ISO norms
- Team capable, Quality driven mind-set, communicative personality with assertiveness and enjoyment of independent and enterprising work
- Open to new ideas and to question conventional thinking
- Practical experience in the implementation and evaluation of risk analysis such as Failure Mode Effective Analysis (FMEA)
- Fluent in both German and English
We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure.
If you are interested in this position, then please apply online including application letter, CV and ideally testimonials.
Primary Location:Europe/Middle East/Africa-Switzerland-Schaffhausen
Organization: Cilag AG (8562)
Job Function: Engineering
Description
Cilag AG, being part of the Janssen Supply Chain and a member of Johnson & Johnson Family of companies, is currently looking for a
Senior Quality Engineer (w/m)
to be based in Schaffhausen, Switzerland.
POSITION SUMMARY:
As a Senior Quality Engineer you will be responsible for the quality assurance of site equipment and facilities qualification in the business units of Pharma, Chemical and Medical Devices operations, Utilities and Information Technology.
You will be the Quality Engineering representative on cross functional teams to develop and deliver projects required to achieve company & departmental goals, as well as the site representative in the key compliance areas for the Janssen Supply Chain.
PRINCIPAL RESPONSIBILITIES:
- Evaluation, optimisation and implementation of the qualification system for Cilag AG, Schaffhausen facility in compliance to the current worldwide regulatory requirements
- Advise qualification/validation aspects in Pharma & Chemical operations, Medical Devices, Utilities and Computer System Validation, with the aim that integrated cGMP documentation shall be produced being compliant with relevant regulatory requirements.
- Assure that such documentation is efficiently produced and supports the on-going development and use of those systems
- Maintain the qualified status of automated and non-automated equipment through appropriate change impact assessments as SME (Subject Matter Expert) for CoC’s
- Cooperation in ad-hoc working groups, quality teams, task forces, representing QA Engineering
- Assessment and approval of SOPs, plans and reports in the task field
- Planning and reporting of the qualification status of cGMP critical systems
- Preparation and active participation as spokesperson in internal and external inspections in the framework of Quality Engineering
Qualifications
- University/Master Degree in natural science or technical degree
- At least 5+ years of experience in qualification/ validation with a proven track record in the regulated environment
- Comprehensive background of Pharmaceuticals and Devices regulations and related ISO norms
- Team capable, Quality driven mind-set, communicative personality with assertiveness and enjoyment of independent and enterprising work
- Open to new ideas and to question conventional thinking
- Practical experience in the implementation and evaluation of risk analysis such as Failure Mode Effective Analysis (FMEA)
- Fluent in both German and English
We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure.
If you are interested in this position, then please apply online including application letter, CV and ideally testimonials.
Primary Location:Europe/Middle East/Africa-Switzerland-Schaffhausen
Organization: Cilag AG (8562)
Job Function: Engineering