Job Summary: The incumbent will provide documentation support for various AR&D functions as determined by project assignments. The position will work closely with AR&D members and cross functional departments to coordinate and facilitate the various needs of the department. Accomplishments will be objectively determined by the successful and timely completion of coordintation and support activities, including documentation creation and implementation. The position exists to support the ongoing creation and execution of the product pipeline for the company.

Job Responsibilities

• 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.