The Digital Validation Solution Expert (ValGenesis) (Validation Master Data Manager and User Support) is a vital member of our Global MSAT & Engineering team (PTT) responsible for maintaining and updating the master data in a centralized paperless validation system at Roche and to provide critical user support within the Roche network. This role involves managing templates and ensuring standardization in our validation system, as well as handling data migration tasks, process change requests, and ensuring accurate record-keeping.
This position requires a strong understanding of the Qualification and Validation business processes, an innovative and problem solving mindset along with a strong ability to work collaboratively with interfaces to Global and Local MSAT, Engineering, Quality and IT organizations.
Key Responsibilities:
Qualifications:
#LI-KH1
This position requires a strong understanding of the Qualification and Validation business processes, an innovative and problem solving mindset along with a strong ability to work collaboratively with interfaces to Global and Local MSAT, Engineering, Quality and IT organizations.
Key Responsibilities:
- Maintain accurate and organized system validation documentation standards, ensuring it complies with regulatory requirements and company policies.
- Collaborate with cross-functional teams, including Quality, Manufacturing, and Engineering, to ensure successful validation systems and qualification activities.
- Investigate and resolve challenging validation issues by applying scientific and engineering principles, and implement corrective actions as needed.
- Collaboration with suppliers to troubleshoot existing issues, test/deploy new features and support new module Master data build.
- Work closely with validation and qualification SPOCs, SMEs and Site Business Process Managers in order to get the aligned business process translated into the form of Master Data and enable Communications to the sites for system adoption.
- Responsible for implementation (as applicable) of changes to the master data, not only from a Specification perspective but into the ValGenesis Software for implementation.
- Manage templates upload and binding to the Content types at all the sites in addition to template revisions.
Qualifications:
- Familiarity with the Valgenesis Validation Lifecycle Management System is required.
- 3-5 years work experience in the pharmaceutical or biotechnology industry with process development, operations/manufacturing, or related experience.
- Proficiency in validation methodologies, risk assessments, and related documentation.
- Experience resolving issues with a variety of project documentation, including business and functional requirements, validation test protocols and technical support documentation.
- Excellent interpersonal and collaboration skills: proven track record of building strong and sustainable relationships with internal and external partners/stakeholders.
- Ability to act as a coach for colleagues with less experience, provide guidance, motivate, and influence other colleagues.
- Demonstrated capability to role model and actively develop effective risk taking and decision making to colleagues with less experience and help develop skills/expertise.
- Proven capability to foresee and solve problems through Identification of med/high opportunities and solutions implementation.
- Excellent communication and presentation skills: exhibits professional maturity, confidence and competence. Strong executive presence and resonant communications at all levels - experience framing communications to fit the audience.
- Ability to synthesize and summarize complex issues and conclusions so as to expedite agreements and decision-making.
- Attention to detail and commitment to maintaining data accuracy and integrity.
#LI-KH1