南投縣南投市5年以上大學
1. Provide Quality Assurance support and/or lead projects in line with Alvogen/Lotus guidelines, procedures, cGMP, and ISPE guidelines and regulations related to authoring, executing, reviewing, and approval of specifications and validation documentation as appropriate according to the Validation Life Cycle, including but not limited to:
- Validation Plans/Protocols
- User Requirement Specification (URS)
- Risk Assessment (RA)
- Functional Specification (FS)
- Configuration Specification (CS)
- Design Specification
- Commissioning
- DQ, IQ, OQ, PQ
- Summary reports
- Requirements Traceability Matrix (RTM)
- Periodic Review, etc.
2. Liaise and coordinate with all departments and relevant key stakeholders (QA/QC, Manufacturing, Engineering, R&D, Regulatory Affairs, IT) in providing quality assurance support for the Validation program.
3. Communicate validation approaches and requirements during audits if applicable.
4. Facilitate a continuous improvement culture with all departments (QA/QC, Manufacturing, Engineering, R&D, Regulatory Affairs, IT).
5. Provide Quality Assurance support for technical problems that impact products and processes.
6. Provide Quality Assurance support in regards to computerized systems and collaborate with equipment owner(s) to ensure the initiation and implementation of change control activities are in accordance with site procedure.
7. Provide Quality Assurance support in regard to deviations/exceptions during qualification activities.
8. Assist in the development of training material for qualification activities.
9. Serve as a Subject Matter Expert to support the organization in maintaining a work environment focused on quality and one that fosters learning, respect, open communication, collaboration, integration, and teamwork.
10. Manage Validation contractors to complete on-site validation, if required.
11. Lead and participate in cross-functional teams as defined by the site management team.
12. Must be able to maintain a “big picture” perspective without losing sight of the details necessary to meet deliverables and deadlines.
13. Interpret Regulatory Authority regulations, guidelines, and policies.
14. Communicate and ensure compliance with Quality objectives, policies, and procedures.