IT Quality Compliance Specialist - Katalyst Healthcares & Life Sciences
Boston, MA 02108
About the Job
Responsibilities:
- 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 Client 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) processes such as incidents, problems, changes, releases, etc.;
- Ensure adequate and timely regulatory compliance support.
- Partner with IT Validation to ensure risk assessments, incident management, and oversight are aligned with 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 others, 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.
- Experience in working in a GXP-regulated industry and preferably in a quality assurance role
- Highly knowledgeable in Software Lifecycle Development (SDLC) and 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
- Ideal candidate would have prior experience with LIMS system (e.g., Labware)
- quality assurance mindset for computer system validation for GxP space.
- regulatory expertise to read and interpret global GXP regulations, as well as data integrity expectations
- expertise performing test scripts, traceability matrices, risk assessment and other validation deliverables, review and approval as a QA
- Experience in the BioTech/Pharmaceutical industry or similar regulated industry required.
- Good understanding of the drug and device development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes.
- Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Pharmacovigilance Practices (GVP), Food & Drug Administration (FDA), and other regulatory requirements; FDA 21 CFR 11, EU GMP Annex 11, and GAMP 5 standards; Data Integrity.
Source : Katalyst Healthcares & Life Sciences
