Overview
On Site
BASED ON EXPERIENCE
Full Time
Skills
Please refer to job description
Job Details
Net 2 Source 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 # | Board # Ext. 509 | Fax:
Office: 270 Davidson Ave, Suite 704, Somerset, NJ 08873
LinkedIn:
Website:
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 # | Board # Ext. 509 | Fax:
Office: 270 Davidson Ave, Suite 704, Somerset, NJ 08873
LinkedIn:
Website: