Manager, Operation GXP Systems-00000NYQ
Description
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
Tasks
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Key point of contact for all Business Owners when bringing in new computer systems or modifying/upgrading existing computer systems.
-
Act as a Business Analyst by working with and supporting System Business Owners with the business deliverables for Computer Systems Validation including but not limited to:
-
Requirements Gathering
-
Testing Requirements
-
Development and Training of Work Instructions and Procedures.
-
Work with the System Business Owner, IT and CSC in planning of validations of GXP systems.
-
Coach and support organizational understanding and adherence to the J&J SDLC and Change Control Systems.
-
Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
-
Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
Qualifications
Qualifications
-
Experienced Business Analyst for Computer Systems Validations of applications in the life sciences industry
-
Demonstrated understanding of FDA and ISO applicable regulations and specifically related to GXP and 21 CFR Part 11.
-
Direct experience GXP validations and must be familiar with all phases of project development using SDLC
-
Strong Technical Writing Skills
-
Demonstrated ability in working in a team environment
-
Approximate experience or equivalent knowledge and skills necessary to satisfactorily perform the position responsibilities.
-
10+ years as a Business Analyst for Computer Systems or experience in Supply Chain/Operations/Master Data Administration
-
6+ years with four-year degree or equivalent preferred.
-
4+ years with advanced degree or equivalent preferred
We are offering you a multifaceted opportunity in a dynamic, international environment with attractive terms and career opportunities.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
AD CODE: J2W: JOBSCH
Primary Location:Europe/Middle East/Africa-Switzerland-Solothurn-Zuchwil
Organization: Synthes GmbH (7111)
Job Function: Operations
Description
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
Tasks
-
Key point of contact for all Business Owners when bringing in new computer systems or modifying/upgrading existing computer systems.
-
Act as a Business Analyst by working with and supporting System Business Owners with the business deliverables for Computer Systems Validation including but not limited to:
-
Requirements Gathering
-
Testing Requirements
-
Development and Training of Work Instructions and Procedures.
-
Work with the System Business Owner, IT and CSC in planning of validations of GXP systems.
-
Coach and support organizational understanding and adherence to the J&J SDLC and Change Control Systems.
-
Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
-
Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
Qualifications
Qualifications
-
Experienced Business Analyst for Computer Systems Validations of applications in the life sciences industry
-
Demonstrated understanding of FDA and ISO applicable regulations and specifically related to GXP and 21 CFR Part 11.
-
Direct experience GXP validations and must be familiar with all phases of project development using SDLC
-
Strong Technical Writing Skills
-
Demonstrated ability in working in a team environment
-
Approximate experience or equivalent knowledge and skills necessary to satisfactorily perform the position responsibilities.
-
10+ years as a Business Analyst for Computer Systems or experience in Supply Chain/Operations/Master Data Administration
-
6+ years with four-year degree or equivalent preferred.
-
4+ years with advanced degree or equivalent preferred
We are offering you a multifaceted opportunity in a dynamic, international environment with attractive terms and career opportunities.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
AD CODE: J2W: JOBSCH
Primary Location:Europe/Middle East/Africa-Switzerland-Solothurn-Zuchwil
Organization: Synthes GmbH (7111)
Job Function: Operations