- Manage and coordinate activities associated with the GxP IT Quality Assurance (QA) program for GPS and R&D computerized systems regulatory compliance across the end-to-end product lifecycle (GPS and R&D) for software development and validation lifecycle activities associated with regulated computerized systems to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and requirements.
- Carries out functions of the GxP-ITQA as directed including but not limited to:
- Review and approval of key computer system Validation Life Cycle (VLC) deliverables;
- Review and approval of test scripts and defects associated with computer system validation;
- Oversight of key Software Development Life Cycle (SDLC) process such as incident, problem, change, release, etc.;
- Ensure adequate and timely regulatory compliance support.
- Partner with IT Validation to ensure risk assessments, incident management and oversight are aligned to corporate and data protection standards.
- Provide backup support for the department as needed and perform other assignments as required.
- Support internal and external (regulatory) inspection activities related to validated systems.
- Provide support to assigned Quality programs, such as Data Integrity Governance, Investigations, Global Quality Headquarters Training and other, as assigned.
- Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team.
- Operate effectively and with minimal supervision, within a team or independently, performing special projects and related duties, as assigned.
- Bachelor's degree in a related field from an accredited college or university, with a minimum of 8 years of related experience.
- Experience in working in a GXP regulated industry and preferably in a quality assurance role
- Highly knowledgeable in Software Lifecycle Development (SDLC) and in review/approval of key computer system validation deliverables
- *Experience in providing quality oversight of software development quality systems such as problem, incident, change,release, deviations, periodic reviews
- Experience in validation of computerized software and related IT controls
- Familiar with validation testing activities and managing defects
- Knowledgeable in 21 CFR Part 11, Annex 11, GAMP and health authority regulations for computerized systems as well as worldwide pharmacovigilance regulations
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IT Quality Compliance Specialist/Analyst - New Brunswick, United States - Innova Solutions
Description
Innova Solutions is immediately hiring for an IT Quality Compliance Specialist/Analyst
Tittle- IT Quality Compliance Specialist/Analyst
Duration -6 months
Location-New Brunswick ,NJ (onsite)
Pay Range*: $ $79.71 per hour.
As a(n)IT Quality Compliance Specialist/Analyst. you will:
Job Description:
The ideal candidate will have:
Thank you
Aritra Roy
PAY RANGE AND BENEFITS:
Pay Range*: $ $79.71 per hour.
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
IT Quality Compliance Specialist/Analyst professionals in New Brunswick
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Selina Caballero
Contract Compliance Specialist
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Astride Noncent
Quality Assurance Analyst