Vacancy expired!
SUMMARY:
Responsible for quality oversight of validation/qualification efforts supporting computerized systems (including equipment/instruments with a computer component) ensuring compliance to quality objectives and regulatory requirements.
RESPONSIBILITIES:
Provides QA oversight for GXP computerized systems and applies risk-based methodology to validation/qualification efforts in compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5.
Provides QA oversight of deviations, CAPAs, and change controls related to GXP computerized systems.
Analyses, develops, tests, and deploys configuration, workflow, and/or reporting to improve the overall accuracy, efficiency, and effectiveness of the electronic computerized system.
Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
Effectively identifies and resolves system issues and appropriately communicates gating items to senior management and stakeholders.
Participate in the development and improvement Quality Assurance programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP) expectations and established agency requirements/guidelines.
Supports the development, collection and management of quality metrics to optimize performance, productivity and effective resource planning.
Supports the external audit program for vendors related to GXP computerized systems.
Participates in cross-functional project teams.
May support and interface with regulatory agencies as required in support of regulatory agency inspections.
Keeps abreast of the requirements for compliance in own area of work. Participates as required in training on regulatory issues affecting own area of work. Notifies manager of regulatory compliance questions and issues.
EDUCATION:
BA/BS or equivalent combination of related education and experience.
EXPERIENCE:
At least 8+ years of relevant progressive experience in the pharmaceutical/biotech industry.
At least 4 years of supervisory/personnel management experience.
KNOWLEDGE/SKILLS:
Comprehensive expertise and working knowledge of 21 CFR Parts 11, 210, 211, 600, Eudralex Volume 4 Annex 11 and 15 and related Annexes, and ICH guidance documents
Experience in providing oversight in implementing and maintaining GXP computer systems in a validated state
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
Strong working knowledge in validation methodology and software development life cycle (SDLC) principles
Demonstrates ability to perform detail-oriented work with a high degree of accuracy
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
Must work effectively within teams with rapidly changing priorities
Vacancy expired!