Date:
26-Jan-2014
Location
Zug, CH
ASP EMEA Supplier Quality Engineer-00000LTV
Description
Johnson & Johnson is the world‘s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related products for the consumer, pharmaceutical and professional markets.
Advanced Sterilization Products (ASP), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers, and communities
Responsibilities
• Supports EMEA Supplier Quality Management group based in Switzerland
• Conduct and manage new and existing supplier assessments to determine the state of Quality Systems, GMPs and Process Capabilities in support of ongoing business and new product introductions
• Ensure that supplier systems are aligned with current regulatory requirements, standards, industry trends, and J&J policies and standards
• Escalate issues and leading risk assessments and risks mitigations as appropriate
• Collaborate with key business partners and drives non-conformance investigations to ensure timely and robust corrective actions
• Communicate product and compliance risk, write, review and execute documents and procedures and participate in investigations or for-cause supplier site-audits
• Monitor, trend, identify issues, and drive the resolution of supplier quality issues as well as execute and lead negotiations of External Manufacturer Quality Agreements
• Act as the process quality subject matter expert on cross-functional project teams, as well as development and analysis of monthly and quarterly metrics
• Be involved in review and approval of supplier change control documentation
• Other responsibilities may be assigned and not all of those listed above may be assigned
Qualifications
Qualifications
• A minimum of a Bachelor's degree in a technical discipline (Math, Science, Engineering or Information Technology) is required; a degree in Engineering is preferred
• A minimum of 1-5 years work experience is required. Experience working in a highly regulated environment (medical device, pharmaceutical, etc.) is preferred
• Direct experience in plant and/or supplier GMP auditing is preferred
• Prior manufacturing, plant or technical background is required
• Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA systems and investigations, laboratory controls, production and process controls, is required
• Experience with documentation and technical writing skills, in a regulated compliance environment, is required
• Quality Auditor or Lead Auditor certification is preferred
• Prior experience with FDA inspections is desirable
• Experience with Six Sigma Process Excellence tools, training and/or certification is desirable
• Broad knowledge of Quality System Regulations and Supplier Quality Management principles is desired
• Demonstrated ability to translate GMP requirements into SOPs and specifications
• Understanding of GMPs as they pertain to manufacturing, testing and packaging of drug products
• Demonstrated ability to identify compliance risks and assess business impact, are required
• Ability to manage complexity and lead a diverse team is essential
• Deal with complex issues using deductive reasoning, critical analysis skills and systematic approaches
• Strong analytical skills, metrics development and ability to identify trends are desirable
• This position may require up to 40% travel domestically and internationally
AD CODE: J2W: JOBSCH
Primary Location:Europe/Middle East/Africa-Switzerland-Zug-Zug
Organization: Cilag GmbH International (8525)
Job Function: Engineering
Job Segment: Quality Engineer, Medical, Manufacturing Engineer, Engineer, Engineering, Healthcare, Quality
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Description
Johnson & Johnson is the world‘s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related products for the consumer, pharmaceutical and professional markets.
Advanced Sterilization Products (ASP), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers, and communities
Responsibilities
• Supports EMEA Supplier Quality Management group based in Switzerland
• Conduct and manage new and existing supplier assessments to determine the state of Quality Systems, GMPs and Process Capabilities in support of ongoing business and new product introductions
• Ensure that supplier systems are aligned with current regulatory requirements, standards, industry trends, and J&J policies and standards
• Escalate issues and leading risk assessments and risks mitigations as appropriate
• Collaborate with key business partners and drives non-conformance investigations to ensure timely and robust corrective actions
• Communicate product and compliance risk, write, review and execute documents and procedures and participate in investigations or for-cause supplier site-audits
• Monitor, trend, identify issues, and drive the resolution of supplier quality issues as well as execute and lead negotiations of External Manufacturer Quality Agreements
• Act as the process quality subject matter expert on cross-functional project teams, as well as development and analysis of monthly and quarterly metrics
• Be involved in review and approval of supplier change control documentation
• Other responsibilities may be assigned and not all of those listed above may be assigned
Qualifications
Qualifications
• A minimum of a Bachelor's degree in a technical discipline (Math, Science, Engineering or Information Technology) is required; a degree in Engineering is preferred
• A minimum of 1-5 years work experience is required. Experience working in a highly regulated environment (medical device, pharmaceutical, etc.) is preferred
• Direct experience in plant and/or supplier GMP auditing is preferred
• Prior manufacturing, plant or technical background is required
• Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA systems and investigations, laboratory controls, production and process controls, is required
• Experience with documentation and technical writing skills, in a regulated compliance environment, is required
• Quality Auditor or Lead Auditor certification is preferred
• Prior experience with FDA inspections is desirable
• Experience with Six Sigma Process Excellence tools, training and/or certification is desirable
• Broad knowledge of Quality System Regulations and Supplier Quality Management principles is desired
• Demonstrated ability to translate GMP requirements into SOPs and specifications
• Understanding of GMPs as they pertain to manufacturing, testing and packaging of drug products
• Demonstrated ability to identify compliance risks and assess business impact, are required
• Ability to manage complexity and lead a diverse team is essential
• Deal with complex issues using deductive reasoning, critical analysis skills and systematic approaches
• Strong analytical skills, metrics development and ability to identify trends are desirable
• This position may require up to 40% travel domestically and internationally
AD CODE: J2W: JOBSCH
Primary Location:Europe/Middle East/Africa-Switzerland-Zug-Zug
Organization: Cilag GmbH International (8525)
Job Function: Engineering
Job Segment: Quality Engineer, Medical, Manufacturing Engineer, Engineer, Engineering, Healthcare, Quality
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