Sr. Quality Specialist, Computer Systems Validation
The Sr. Quality Specialist, Computer Systems Validation individual is responsible for providing Quality & Compliance oversight to ensure compliance with Computer System Validation (CSV), Systems Development Lifecycle (SDLC) and Data Integrity.
Provide compliance leadership, direction and execution in Computer System Validation activities.
Participate in project teams and author (as applicable), review and approve computer validation related documentation including but not limited to: risk assessments, validation plan, user requirements, specifications, UAT, traceability matrix, testing (FAT, SAT, IQ,, OQ/PQ), data migration, qualification/validation protocols and reports.
Coordinate with other departments or outside contractors/vendors to complete validation tasks.
Support resolution of project deviations/errors and provide quality guidance on GxP regulatory requirements.
Investigate and troubleshoot problems which occur and determine solutions or recommendations for mitigation and/or improvements.
Identify current and anticipated requirements for compliant computerized operations and suggest methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
Participate/lead in the review of current and future SDLC/CSV policies and procedures.
Participate in regulatory audits and communicate company's computer validation policies.
Prepare plans for remediation of legacy systems and implementation of new systems.
Conduct validation training with project team communicating deliverables, procedures and methods.
Manage projects and prepare status reports as applicable.
Provide compliance support, guidance and expertise.
Knowledge of 21CFR Part 11 and GAMP V.
Understanding of GxP regulations and computer validation principals.
Understanding of software development lifecycles.
Understanding of document management principals.
Demonstrated technical writing and oral communication skills.
Scientific education or experience, with test script design, technical document reviews preferred.
Knowledge of cGMPs and regulatory requirements.
Bachelor’s degree in Engineering, Computers or related field.
8+ years in a GMP regulated environment with related CSV industry experience (Pharma/Biotech). Validation experience with ERP, LIMS, and Quality Systems preferred.
High attention to detail, quality and compliance with strict adherence to procedures and protocols.
Strong knowledge of computerized system development life cycle approach is required.
The ability to work and make decisions independently and have the flexibility to adapt to changing priorities is required.
Strong leadership skills and the ability to work in cross-functional team environments, as well as independently.
Project management experience preferred.
Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with vendors, contractors and external customers.
Demonstrable analytical and systematic problem solving skills.
Ability to liaise with cross-site networked/matrixed IT and Quality functions.
Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based on changing priorities.
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