Change & Documentation

PURPOSE

Governance to ensure that all the implementation of change request is well managed and align with regulatory requirement and Bayer Compliance Management System. Coordinate with all departments to ensure all of GMP documents are in effective status and align with Bayer Compliance Management System.

MAJOR TASKS & RESPONSIBILITIES

1. Governance of change management and documentation management procedure in Bayer Cimanggis to ensure that all aspect for the implementation of a change are adequately documented and corresponding activities are defined assigned by setting up the task list/timeline considering stakeholder’s feedback and all potential impact of the change on the product and its supply.
2. Control electronic and non-electronic documents so that only effective/ valid documents are located in the Cimanggis Site.
3. Ensure GxP System Implementation as controlled document performed properly and correctly.
4. Ensure no overdue SOP in each area/ department by coordinating periodic review SOP activity.
5. Coordinate change management activity and the implementation of site related change request and ensure compliance of implementation as per procedure and check the effectiveness.
6. Responsible as local process owner on managing change management system (SYNAPS, BASICS) and PDV system.
7. Responsible as local process owner on managing documentation management system (IQMS, Docusign).
8. Ensure 100% CMS implementation in change management and documentation management area.
9. Quality Management Review (QMR) supported data from Change Management and Documentation Area in timely manner.

SKILLS & REQUIREMENT

• Pharmacist with minimum 1 years experience in GMP aspects, Quality Assurance.
• Familiar with international and local GMP principles for manufacturing of pharmaceutical products and Food supplements.
• Team player who is also able to work independently and deliver results with minimal guidance.
• Pay attention to details and focus to quality of works.
• Professional English skills and skilled to work within an international team.
• Good problem-solving abilities.
• Good organizational and time management skills.
• Proven flexibility and adaptability.