Computer System Validation Specialist
Plans, coordinates, and implements validation activities for computer systems, hardware, and software in a GMP environment. Creates computer system validation documents and testing protocols according to GAMP best practices. Collaborates with key stakeholders of Quality, Production, FAS, Commercial, Business, and enterprise software applications. Ensures validation plans for computer systems are compliant with industry regulations including CGMP, GAMP, and FDA 21 CFR Part 11.
- Authors risk assessments, business requirements, validation plans, change requests, test scripts, SOPs, qualification deliverables (DQ, IQ, OQ, PQ), and other relevant computer systems validation documents.
- Performs all aspects of Quality Management System (QMS) processes (change control, deviation, CAPA, maintenance) relating to validated computer systems.
- Works closely with Quality Assurance in qualification and validation activities.
- Maintains full understanding of current industry regulations and best practices for Data Integrity, including GAMP and 21 CFR Part 11.
- Maintains current knowledge and understanding of the company's QMS, policies, and procedures.
- Participates in audits and inspections as a Subject Matter Expert.
- Provides backup support for the IT department as needed and perform other assignments as required.
- Ability to write excellent and effective validation documents compliant with Good Documentation Practices (GDocP).
- Thorough understanding and compliance to industry standards for Data Integrity.
- Solid understanding and consistent application of the effective relationship between SOP authoring, training, and compliance.
- Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team.
- Experience with and understanding of relevant GxP systems such as quality management systems, document management systems, clinical and laboratory systems.
- Thorough understanding of IT systems, services, and infrastructure.
- Experience with and understanding of business and quality enterprise applications (ERP, CRM, eQMS, groupware, etc.).
Education and Experience
- Bachelor’s degree in Information Technology, Computer Science, Information Systems, or related field; or equivalent combination of IT-industry certification and experience.
- 3 – 5 years’ experience in comparable position(s) within the pharmaceutical, biotech, or CDMO industry required.
- Experience creating and reviewing validation related deliverables described above.
- Requires 3 years of GMP experience.