- Assist Quality Systems and Compliance Team in project work for assigned computer systems assessment, implementation and enhancement projects and system rollout.
- Serve as QA Lead on systems implementation projects, quality records, and steady state activities.
- Provide support to ensure system qualification/validation activities are planned, executed, and finalized in compliance with regulatory requirements and Client's policies and SOPs.
- Support Data Integrity program by serving as QA Lead on gap assessments, risk assessments and remediation plans.
- Develop SOPs, review and approve Validation strategy, plans, protocols, procedures.
• Attend project meetings and workshops. - Assure system artifacts are in accordance with Client policies, standards, SOPs and meet regulatory standards.
- Serve as QA SME under the supervision of the assigned Client QSC Leadership.
- Perform duties as assigned by Client QSC Leadership.
- Assist in the maintenance of the site-based computerized systems.
- Assist in the assessment, review, and approval of change controls, deviations, and CAPA's.
- Comprehensive expertise and working knowledge of 21 CFR Parts 11, 210, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents
- Extensive knowledge and competence in core Quality processes, including change control, training, deviation, CAPA, risk management, and vendor management.
- Strong working knowledge in validation methodology (including GAMP) and software development life cycle (SDLC) principles.
- Experience in providing oversight in implementing and maintaining GXP computer systems in a validated state.
- Excellent verbal, written and interpersonal communication skills.
- Effective time management and interpersonal skills.
- Strong organizational skills, planning skills, and must work effectively within teams.
- Demonstrates good coping skills and analytical problem-solving skills.
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Quality Assurance Compliance Specialist - Newark, United States - Harvey Nash
Description
Role: Specialist Quality Systems and Compliance IV
Loc: Newark, CA (hybrid)
Duration: 6 months contract with possible extensions
SERVICES and DELIVERABLES:
In support of Client's Quality Systems and Compliance initiatives, Service Provider shall perform the Services identified below and deliver to Client the Deliverables identified below.
Services: This Scope of this contract covers the role of Quality Assurance Specialist at the Newark Facility, to support compliance of all applicable computerized systems.
Skills
Education
BA/BS or equivalent combination of related education and experience.
