Key Responsibilities/Essential Functions
- Author and manage the execution of Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, CGMP and ISPE GAMP5 guidelines and regulations.
- Conduct vendor assessments for validation deliverables.
- Act as Study Director to initiate and facilitate Quality Change Controls and task assignments.
- Guide testing and compliance efforts to ensure regulatory, quality, and safety priorities are adequately addressed.
- Work with computer system owner(s) to ensure implementation of change control activities are in accordance with site procedures.
- Participate in requirements gathering for user, functional, and system requirements.
- Mentor team members on how to best meet compliance objectives and strategy, and implement into operational practices.
- Ensure validation deliverables are in alignment with ISPE GAMP, cGMP, Annex 11 and Data Integrity regulations, and Computer Master Validation Plan (VMP) guidelines and procedures.
- Effectively facilitate meetings to discuss and complete risks assessments required by GxP and 21 CFR Part 11 compliance guidelines and the Site Computer VMP.
- Liaise with other departments to identify SOPs that need to be created, revised, removed, or replaced.
- Maintain oversight of the User, Functional, and System Requirements to meet the IQ/OQ/PQ testing objectives while managing a Traceability Metrix to verify all testing is conducted and properly documented.
- Author summary reports for executed Validation protocols.
- Communicate Computer System Validation approaches and requirements during audits.
- BS/BA degree in a computer science/ business/technical discipline with a minimum of 10+ years of experience in CSV in a pharmaceutical industry or related GMP environment, or equivalent.
- Self-motivated with the ability to prioritize, meet deadlines, and manage changing priorities.
- In depth knowledge of FDA guidelines and Global cGMPs relevant to 21 CFR Part 11 compliance requirements, Global Computer System Validation, and ISPE GAMP5 guidelines.
- Strong verbal and written communication skills, collaboration skills, decision making skills, and time management skills is required.
- Demonstrated analytical and problem solving skills and the ability to work in a team dynamic throughout all levels of the organization.
- Ability to team with project managers and IT/business leads in translating validation constraints and sequence into clearly-defined project dependencies.
- Ability to build validation project sites that assist in information sharing, qualification coordination and tracking, and interim document tracking.
- Ability to effectively and efficiently translate compliance priorities into design, testing, documentation and project objectives.
- Knowledge of the following IT concepts: SDLC, system architectures, layered solutions and designs, technical standards, hosted environments, virtual environments, database design, networking, web development.
- Experience in development and implementation of standards, procedures and guidelines in support of a validated operational processes.
- Non routine overnight travel based on business need