The QA Computer Systems Validation Lead is a key technical role responsible for the Quality lifecycle management of GxP Computer System Validation (CSV) and Qualification activities in accordance with industry standards and regulatory guidance. As such, this position will require demonstrated leadership and project management skills including, but not limited to planning, monitoring, execution, control, and delivery.
The candidate will work closely with all departments to provide expertise in CSV compliance, manage/escalate identified issues, and support continuous improvement.
- Responsible for all services related to Computer System Validation (implementation, oversight, and management), including Part 11 Assessments, Qualifications, maintenance of qualified state, and data integrity.
- Author (individually and in a team setting) all required documentation to support CSV process, including but not limited to: Design Qualifications, Functional Requirements, User Requirements Specifications, UAT scripts, validation plans, validation summary report, traceability matrix, IQ/OQ/PQ.
- Generate and maintain Computer System Validation policies, procedures, templates, forms, inventory lists, roadmaps, and business continuity plan(s) both internally and with vendors that are in line with corporate procedures, cGMP, and GAMP guidelines.
- Conduct audit trail reviews for systems based upon procedural frequencies.
- Perform risk assessments with functional teams to assess system risks and develop mitigation plans.
- Serve as the SME and maintain knowledge and information in the CSV area of expertise.
- Collaborate with IT to gather infrastructure and architectural requirements pertaining to relevant projects.
- Function as the QA CSV Subject Matter Expert (SME) in support of audits and regulatory inspections.
- Develop and evaluate quality processes and system standards to ensure compliance with applicable procedures, industry standards and global regulations.
Skills & Requirements
- Thorough experience with and knowledge of cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11, GAMP, and data integrity standards.
- Initiate and support change control activities, deviations, and other Quality System documents for Computerized Systems.
- Maintain up-to-date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer systems, and act as an information resource for the team and wider business.
- Previous experience working with change management systems is a plus.
- Ability to proactively identify and implement continuous improvements.
- Strong English verbal and written communication skills, good decision-making skills and time management skills are a must; ability to interface with all levels of the organization.
- Strong organizational and planning skills.
- Ability to interact with a multi-disciplinary team and lead all Computer System Validation projects for the company.
- BS or at least 8+ years of hands-on experience in CSV, with an understanding and knowledge of the use of electronic systems in a pharmaceutical or similar regulated industry (i.e. GMP/GDP environment) required.
- Proven track record in writing and executing validation and qualification of complex computer systems; and in planning, writing, and executing qualification protocols.
- Demonstrated strong project management experience and skills.
- Experience in employing risk-based approaches to CSV.
Submit your resume below or send your resume to [email protected].
Pyros is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances.