Reporting to the Head of System Qualification and Validation, this position plays an integral role in oversight of facilities systems, utilities, process equipment, GxP validation and change management of computer systems compliance. The cross-functional role will work to drive continuous improvement across all GxP systems and equipment while serving as the primary point of contact for computer systems validation.
Responsibilities (including, but not limited to):
- Quality Assurance Validation (QAV) Responsibilities:
- Serve as the Quality lead for lab and process equipment design, qualification, and maintenance/calibration to ensure it remains in a state of control
- Support the Quality Management System (QMS) to monitor and improve processes within the GxP QMS framework
- Identify and track progress against key project milestones partnering with applicable business process, equipment, and facilities owners along with any external providers to ensure overall project success and compliance
- Work effectively across the matrix by engaging with the broader process owner network and site or function process owners in designing and deploying systems
- Serve as the subject matter expert (SME) regarding Data Integrity
- Computer Systems Validation (CSV) Responsibilities:
- Author Validation Plan, Design Specification, IQ, OQ & PQ Protocols, Traceability Matrix and Validation Summary Reports for assigned projects
- Manage authoring and dry running of IQ, OQ and PQ test scripts
- Develop preparation of all validation deliverables for approval
- Author and manage resolution and final disposition of all deviations identified during test execution
- Maintain CSV master list and manage and carry out periodic reviews of CSV
- Support vendor audits and supplier approval process associated with CSV
- Support computer systems Risk Based Assessment (RBA) and gap assessment remediation activities
Qualifications:
- A Bachelor's degree with 5+ years' pharmaceutical industry experience
- Previously served as SME for data integrity
- Strong knowledge of relevant Quality compliance processes and regulations (e.g., Good
- Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP))
- Familiar with electronic quality system tools (e.g., Veeva Vault)
- Demonstrated system quality and compliance knowledge of GxP regulations (21 CFR Part 11, Annex 11 & GAMP5, etc.)
- Experience in creation/maintenance & implementation of SOPs
- Program and project management experience
- Excellence teamwork, interpersonal, and communication skills
- Comfortable working in a dynamic and changing environment
- Ability to provide innovative ideas or alternatives that create value including seeking new
- information and external insights without compromising compliance
