CSV Lead

2 weeks ago(1/4/2018 2:58 PM)
ID
2017-7916
# of Positions
2
Work Location (City/State)
Somerset, NJ

Who We Are

GalaxE.Solutions

Every day, our solutions affect people throughout the world. From Fortune 100 companies to start-ups, GalaxE develops and implements strategic projects that are critical to the success of customers’ businesses and the lives of tens of millions of people.

 

For over twenty-five years, we have grown and evolved into a multi-national firm that employs over 2000 team members worldwide. But we’re not done evolving. It took collaboration and innovation to get here, and it takes collaboration and innovation to get where we (and our customers) want to be tomorrow.  

 

What does this mean for our employees? They have the security of an established company, with the benefits of working for a company where great minds, hard work, leadership and innovation are highly regarded and rewarded.

 

As Thomas Edison said, “There’s a way to do it better – find it”. We want our employees to find it.

 

We’re looking for creative people, with an entrepreneurial spirit, looking to work on awesome projects! Sound like you? Come work with us! Find out for yourself what it means to be part of the GalaxE team.

 

It’s not always easy, but important work never is. #WeAreGalaxE

 

Equal Opportunity Employer/Veterans/Disabled

What You Will Do

Job Duties:

  • Develop a plan for the validation of computer and automation systems ensuring compliance to required regulatory requirements.
  • Partner with the Global IT Compliance organization to gain in-depth understanding of guidelines, requirements and general expectations related to Computer Systems Validation and Compliance
  • Deliver validation activities in compliance with US and EU regulations.
  • Participate in the design of systems and equipment, if needed, to ensure that they comply with GMP/GCP/GLP requirements.
  • Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
  • Initiate and implement change control activities in accordance with site procedures.
  • Compile and analyze validation data and make recommendations for improvements.
  • Participate on cross-functional project teams with the support of Validation activities.

Leadership Responsibilities:

  • Manage a team of CSV contractors in the development and execution of all validation documentation specific to the defined application development (Project ) consistent with Clients' SDLC and IT Compliance standards
  • Give guidance on all activities related to computer and automation system validation.
  • Prepare and deliver regular updates and communications (verbal and written) to the team and extended business partners regarding the progress of the Validation work stream.
  • Review and approve documents prepared by the validation team, other departments and contractors (e.g. test plans, impact assessments, change controls, etc.).
  • Contribute directly to the completion of projects through the management of assigned contract personnel, if applicable.
  • Coordinates and executes training of required personnel on the computer and automation systems validation procedures and methodology.
  • Prioritize qualification activities in line with the project schedule.

Day to Day Technical Responsibilities:

  • Author relevant validation documentation (e.g. Master Plans, Test Scripts, Templates, etc.), as defined by the Client's IT SDLC methodology.
  • Execute all relevant validation protocols and test procedures, as defined by the Clients' IT SDLC methodology
  • Develop validation documentation as required (e.g. specifications, user requirements, plans, protocols, procedures, traceability matrix, error/defect reports, etc. ).
  • Execute qualification protocols as required.
  • Prepare reports of executed protocols for review by QA.
  • Track and resolve exceptions during qualification activities.
  • Proactively resolve conflicts between compliance requirements and project/business constraints.
  • Co-ordinate validation activities with IT, Business, QA activities.

Skills and Experience You Will Need

Mandatory Requirements:

  • 10+ Years: Computer System Validation
  • 6-8+ Years: Medical Devices industry experience
  • 5+ Years: Demonstrated leadership in SDLC/CSV, IT Compliance and/or IT Quality Assurance
  • Experience with Managing/Training Offshore resources.
  • Experience with equipment controlled by ERP, LIMS, EMS, PMS, and other Quality and Development Laboratory systems.
  • Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11, 820 and GAMP standards are required.
  • Root cause analysis; experience investigating and troubleshooting automation and control systems
  • Strong leadership skills and the ability to work in cross-functional team environments, as well as independently, and to manage multiple and competing projects are required.
  • Strong written and verbal communication skills
  • Knowledge of MS Office, SharePoint, MS Project, and Visio.


Desired Requirements:

  • Knowledge/familiarity with U.S. and Global regulatory registration of drug products is preferred.
  • International, cross culture, and cross functional experience desired
  • Project management skills

 

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