About the role
- Responsible for creating and managing project documentation, including change control documents, raw material specification, forms, protocols, reports, and other documents as assigned to support AR&D needs.
- Co-ordinate with QA for Change request for all project related activities.
- Co-ordinate with QA department to make specification/test methods effectiveness.
- Responsible for coordinating with the Purchasing Department as required for API related documents to support project needs.
- Responsible for assisting with the DMF review.
- Responsible for assisting in communication of general AR&D requirements to other departments.
- Responsible for supporting or assisting with the stability protocol preparation.
- Responsible to co-ordinate with regulatory department for any analytical documents requirements.
- Responsible for operating in accordance with the company’s Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
- Other related responsibilities as assigned by R&D management.
Major Duties
- Creation of specifications for raw materials and supplies for R&D projects, and collection of documents required to support raw material assessments
- Creation of method validation/verification/transfer Protocols/reports, analytical test procedure, summaries, and other related documentation.
- Review and assess DMF to support API related analytical documents for development projects
- Work with offsite groups to assist with the transfer of information to the Aveva site in support of R&D Projects
- Assist with the document review, preparation of project requirement, data compilation to support project requirements under supervisor guidance.
- Carry out change control process for any document preparation in trackwise system.
- Work with AR&D leads to satisfy project requirements.