About the Role
The LPO (Local process owner) & GET Lead for Computer system validation (CSV) & data integrity (DI) will be the site wide local process owner and driver for all existing CSV & DI efforts in the GET departments, and will also act as the overall site Local Process Owner (LPO) across departments. The LPO acts as the subject matter expert (SME) for the process, supports continuous improvement, and represents the process during internal and external audits or regulatory inspections. On-site presence is required for min 60%.
Essential duties and responsibilities include an ‘in-depth’ level understanding and site level ownership/accountability for CSV/DI processes.
Responsibilities
* Owns GET departmental level uplift plans & oversees remediation execution to assure compliance with regulatory requirements
* Own site procedures (SOPs, work instructions) related to the CSV/DI element and assure they are current, accurate, and effective
* Own corresponding training material / provide training and guidance to site personnel on CSV/DI (sub) element expectations and best practices
* Act as site SME and spokesperson during regulatory inspections and internal quality reviews
* Maintain a close partnership with global process owners where existing
* Maintain close partnership and ongoing alignment with assigned domain QA partner(s)
* Support exchange of best practices through engagement in the site LPO community and other global governance structures such as Communities of Practices to build an E2E understanding of all business processes .
Qualifications
* Deep understanding and experience of computer system validation and data integrity in a pharma manufacturing environment (21CFR Part 11, EU Annex 11 + GAMP good practice guides)
* Experience in API environment preferred with knowledge of systems like DeltaV, PI, PCS7 along with practices as effective alarm management
* Deep understanding of both FDA and EMA requirements towards CSV and Data integrity, including hands-on experience with risk-based approaches and creation of validation documents
Required Skills
* Excellent project management skills, organizing, planning and coordination skills
* Strong interpersonal & communication skills
* Experience in leading teams in complex / dynamic environments
* Coaching, human change management and training skills
* Ability to navigate politics, interact at different levels of the organization, and influence without authority
* Languages; English (must), Dutch (preferred)