- 非公開 No.DS1829-16
- Position Overview
This position is critical to ensure sustainable compliance of site products and processes, procedures and systems with MMD requirements and regulatory requirements and expectations.
Under his/her responsibilities fall the quality oversight and management for
•Receipt, handling, storage, and disposition of products and components
•Batch record review
•Exception based processing of materials
•Corrective and preventive actions (CAPA) investigation, management and approval
•Annual Product Reviews/Annual Product Quality Reviews for the site’s products
•Supplier quality management.
The incumbent interfaces with all site functions and the global Quality organization (collaboratively with Quality Assurance Manager) with regards to the above described activities. The role has newly formed with organizational changes, thus shifting of responsibilities in near future is acceptable.
1.Ensure that adequate controls and procedures are in place for the receipt, handling, storage, and disposition of components, containers and closures, in-process materials, packaging materials, labeling, drug substances incl. intermediates and drug products incl. intermediates. Provide quality oversight for such activities.
2.Ensure that adequate processes and procedures are in place and followed for batch record review.
3.Ensure that product returned for salvage and product subjected to improper storage conditions during shipping is properly assessed and its disposition decided.
4.Authorize any exception based processing of materials (e.g., conditional, reprocessing, reworking, repackaging) and any transfer of unreleased materials within MMD in accordance with MMD requirements and procedures.
5.Oversee, manage and approve corrective and preventive actions (CAPA) related to components, containers and closures, in-process materials, packaging materials, labeling, drug substances and drug products and associated facilities.
6.Provide Quality oversight and approve deviation investigations.
7.Perform or review Annual Product Reviews/Annual Product Quality Reviews of each product manufactured on site. Utilize annual data to identity system or process improvements and ensure their implementation, as appropriate.
8.Provide Quality Oversight for all suppliers managed by the site including signing of local Quality Agreements and change management in case of supplier changes initiated by the site.
- Degree in Life Sciences, Engineering or related relevant discipline.
Minimum of 5 years’ experience in the regulated pharmaceutical environment; preferably in a manufacturing site in quality (including QC) and/or manufacturing roles.
Demonstrated depth knowledge of Japanese and global authority quality and compliance requirements
Knowledgeable in Industry Best Practices for quality and compliance related topics.
Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site and with other Quality functions on global and local level.
Proven ability to effectively initiate and drive change across the site.
Strong verbal and written communication skills, preferably project management skills.
Demonstrated ability to make and act on decisions while balancing speed, quality and risk.
Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
Good Japanese and English communication skills