Company OverviewSenior Specialist or Specialist Quality Operations - Top Global Mega Pharma Company
Job DescriptionPosition Overview – Basic Functions & Responsibility
This position is critical to ensure sustainable compliance of site products and processes, procedures and systems with our requirements and regulatory requirements and expectations.
Under his/her responsibilities fall the quality oversight for
- Receipt, handling, storage, and disposition of products and components
- Batch record review and Release
- Deviation investigations
- Corrective and preventive actions (CAPA) investigation, management and approval
The incumbent interfaces with all site functions and the global Quality organization (collaboratively with Quality Operations 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. Establish adequate controls and procedures 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.
2. Ensure that adequate processes and procedures are in place and followed for batch record review.
3. Participate and/or Lead investigations with collaboration of other departments, generate deviation reports, perform trend analysis of root causes on a periodic basis.
4. Manage 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.
5. Perform 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.
6. Represent quality, provide quality oversight in complex projects or initiatives such as new product introduction.
7. Participate in continuous improvement initiatives and be act as a change agent to initiate such activities
• Degree in Life Sciences, Engineering or related relevant discipline.
• Minimum of 5 years’ experience in the regulated pharmaceutical environment (pharma or medical device); preferably in a manufacturing site in quality (including QC) and/or manufacturing roles.
• Knowledgeable 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.
• Preferably have project management skills.
• Be ready to act as change agent
• Good Japanese and English communication skills (TOEIC 750 or more)