Full-Time QA Release Associate Manager
Job Description
This position has responsibility for disposition of products that originate from third party and Ferring affiliate sites. Functions to ensure that products are available to meet business objectives through resolution of investigations/deviations and management of change control activities. Also responsible for the oversight of the warehouse/distribution center, process improvements, facility audits and deviation/CAPA management.
- Assemble and maintain batch documentation for commercial products. Interface with internal and external partners to resolve outstanding issues. Perform final release of finished products.
- Perform timely release of products to meet business objectives
- Manage internal Deviations. Ensure transport deviations are registered and resolved.
- Resolve all un/planned events at the third party warehouse/distribution center to ensure product supply
- Review and approval labelling and component specifications
- Preparation, and review of Annual Product Reviews
- Other projects as assigned by Quality Assurance and GQA Management
- Prepare quality documents to support Annual Reports and other regulatory submissions
- Support periodic and for cause audits of existing and new GMP vendors
Qualifications
- BS Degree in natural sciences, engineering of pharmacy from an accredited college or university.
- A minimum of five (5) years consecutive experience in the biopharmaceutical, combination product and/or medical device industry
- Proven experience with supplier audits Certified Lead Auditor (ASQ), highly preferred
- Experience with providing direct oversight and support to commercial large molecule manufacturing sites, including internal and external sites
- Comprehensive understanding of GMP including 21 CFR Part 4, 210/211, and 600. Experience with 803, 820, ICH Guidelines, ISO 13485 and EU regulations, highly preferred
- Expert proficiency in MS Office applications and working knowledge of Trackwise.
Additional Information
All your information will be kept confidential according to EEO guidelines
How to Apply
Click here to apply:https://smrtr.io/fDW99 |
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