CSV Specialist with QMS and life science - Net2Source
MOFFETT FIELD, CA 94035
About the Job
Net 2Source Inc
is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries
We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants
Role CSV Specialist with QMS and life science Location – Mountain View, CA - Onsite Hire Type: Fulltime - Permanent Role Description We are seeking a highly skilled and experienced CSV Specialist who will play a crucial role in planning and executing the validation of computerized systems which support applications, medical devices, and quality management system by ensuring compliance with industry regulations and standards
This individual plays a key role in implementation, maintenance, and retirement of regulated computerized systems which are considered as non-products
Role Responsibilities Work with software vendors and internal cross functional teams to ensure systems are appropriately validated, implemented, and maintained in accordance with current industry practices
Provide CAPA, audit, and overall QMS support in regards to eQMS
Act as SME for CSV and IT Infrastructure related projects to guide product and IT teams to ensure that a consistent approach is utilized in the validation and qualification activities
Qualifications: 4+ years of work experience, preferably in a regulated industry, e.g
medical device, pharmaceutical under good clinical, laboratory, manufacturing, and distribution practice (GxP) environments
Working knowledge of GxP regulations, CSV/CSA principles, including, but not limited to: 21 CFR Part 11, Annex 11, GAMP 5, Data Integrity, FDA QSR, ISO 13485, and/or EU MDD/MDR, ICH 10
Understanding and execution of Computer System Validation practices and processes in the life science industry, including validation of SaaS, IaaS, PaaS
Demonstrated ability to implement and improve CSV processes using SDLC best practices
Skilled in handling end-to-end CSV projects implementation and application of project controls, including familiarity with all project lifecycle phases from requirement gathering through delivery, issues/risk management, change management, release management
Preferred Comfortable with Apps for Work applications and experience using SQL and data analytics platforms
Working knowledge of database management, software test tools, project management methodology, change control, quality and system performance methods and metrics Regards, Prashant Singh Sr
Account Manager - Enterprise Business Net2Source Inc
Direct #
509 | Fax:
is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries
We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants
Role CSV Specialist with QMS and life science Location – Mountain View, CA - Onsite Hire Type: Fulltime - Permanent Role Description We are seeking a highly skilled and experienced CSV Specialist who will play a crucial role in planning and executing the validation of computerized systems which support applications, medical devices, and quality management system by ensuring compliance with industry regulations and standards
This individual plays a key role in implementation, maintenance, and retirement of regulated computerized systems which are considered as non-products
Role Responsibilities Work with software vendors and internal cross functional teams to ensure systems are appropriately validated, implemented, and maintained in accordance with current industry practices
Provide CAPA, audit, and overall QMS support in regards to eQMS
Act as SME for CSV and IT Infrastructure related projects to guide product and IT teams to ensure that a consistent approach is utilized in the validation and qualification activities
Qualifications: 4+ years of work experience, preferably in a regulated industry, e.g
medical device, pharmaceutical under good clinical, laboratory, manufacturing, and distribution practice (GxP) environments
Working knowledge of GxP regulations, CSV/CSA principles, including, but not limited to: 21 CFR Part 11, Annex 11, GAMP 5, Data Integrity, FDA QSR, ISO 13485, and/or EU MDD/MDR, ICH 10
Understanding and execution of Computer System Validation practices and processes in the life science industry, including validation of SaaS, IaaS, PaaS
Demonstrated ability to implement and improve CSV processes using SDLC best practices
Skilled in handling end-to-end CSV projects implementation and application of project controls, including familiarity with all project lifecycle phases from requirement gathering through delivery, issues/risk management, change management, release management
Preferred Comfortable with Apps for Work applications and experience using SQL and data analytics platforms
Working knowledge of database management, software test tools, project management methodology, change control, quality and system performance methods and metrics Regards, Prashant Singh Sr
Account Manager - Enterprise Business Net2Source Inc
Direct #
(201) 285-5087
| Board # (201) 340-8700
Ext509 | Fax:
(201) 221-8131
Office: 270 Davidson Ave, Suite 704, Somerset, NJ 08873 LinkedIn: https://www.linkedin.com/in/prashant-singh-b1b23526
Website: www.net2source.com
Source : Net2Source