Quality Assurance R & D

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POST DATE 8/9/2016
END DATE 12/19/2016


Andover, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #


12 months

BA/BS in Science, Engineering, Pharmaceutical Sciences or related technical discipline
Min. 5 years of experience in GXP setting (or 3 years with Masters degree)
Advanced in computer skills such as MS Office applications and good knowledge of enterprise systems such as Trackwise.
Good command of English language
Good verbal and written communication skills and able to work in diverse multi-level, cross-divisional and multi-cultural working environment
Show strong negotiation skills and customer focus
Demonstrate ability to prioritize work, manage multiple projects act and work independently
Take initiative and be proactive
Up to 10% travel required

Initiate, review and approve regulatory changes through our Product Dossier Manager (PDM) for changes initiated by or impacting COQA managed contractors.
Review and approve master material workflows submitted via SAP
Initiate, review and approve suppliers in our supplier management system (SMS). Corresponding with CQLs to ensure all suppliers for the contractors that they have oversight for have been entered into our system.
Provide support for the closure of the deficiency letters and CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations.
Serve as the main point of contact for the Global Chemistry, Manufacturing and Controls (GCMC) department or Local Regulatory Affairs in the Country Offices (for Single market products) for the various regulatory activities involving the COQA managed contractors.
As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meeting for COQA managed contractors and if needed, participate in Site Quality visits at the contractors.
Manage routine Customer Quality complaints for commercial Drug Products in PCOM and work in collaboration with the COQA Contractor Quality Lead for ensuring that the investigation reports are appropriate and acceptable. Ensure timely closure of complaints and alerting the appropriate colleagues for the confirmed complaints.
Support and Perform Lot Disposition for products in collaboration with others as applicable.