Job Description
Support the Quality Assurance activities of the Marketing Authorization Holder as described below:- Ensure the implementation of GQP Quality Assurance activities and ensure activities operate within established policies/procedures, global requirements, and all applicable regulations.
- Establish and maintain robust local procedures to support GQP operations.
- Manage and work closely with manufacturing sites to ensure effective and robust Quality Management Systems are in place.
- Manage manufacturing site deviations, significant investigations, and change controls as the Marketing Authorization Holder via strong collaboration with Operations and Technical functions including Global functions.
- Support change control activities associated with regulatory filing updates and new product filings and launches.
- Support routine GMP audits of manufacturing sites including gap remediation.
- Support the review of Annual Product Reviews of manufacturing sites.
- Support compliance activities associated with Japan Pharmacopeia and other compendial updates and changes.
- Support Quality and Compliance activities associated with regulatory requirements and regulatory notices.
- Conduct Quality due diligence activities for pre-approval of new external partners.
- Support Quality activities and engage with external partners for various business deals.
- Support GQP regulatory inspections for Marketing Authorization license renewal.
- Collaborates cross-functionally with stakeholders including Regulatory Affairs, Pharmacovigilance, local and global manufacturing sites to support GQP activities for compliant and stable supply of products.
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.