Description
Senior Manager Quality AssurancePosition Responsibilities/Accountabilities:
Participate in the ongoing operations of Quality Control Activities associated with lot release, stability and investigational studies of Drug/Device Product, including the following activities:
* Manage contract QC testing of suppliers for GMP compliance ( US, Europe and Japanese requirements) and technical review which includes:Lot release testing and certificate of analysis
* Stabiltiy testing
* Investigational studies
* New test method validation
* Method transfers
* In-process testing
* Review supplier deviations and Out of Specification test result events associated with testing and manage Incline discrepancy systems for QC data.
* Manage Change Control requests for new or revised specifications with vendors. Track status of the CCR and compile CCR files for QC documentation.
* Conduct and manage trend analysis of QC data.
* Participate in Change Control Requests (CCR) for assessment of impact to QC testing.
* Review and approve method transfer, validation and analytical equipment protocols and reports.
* Participate in the Supplier (contract testing laboratotries) Qualification and oversight program, and perform supplier audits
* Coordinate with Document Control for document reviews and participate as an approver for documents such as Incline SOPs, Incline deviations, CCRs, CAPAs that are associated with QC testing.
* Participate in the review, proof reading, and audit of CMC submission sections in support of Regulatory Affairs.
This position reports to the Senior Director, Quality.
Job Specifications:
Education BA or BS required,
Typical Experience 5+ years experience in pharmaceutical Quality Control organizations
Fields of Expertise Management/communications with Contract Testing Laboratories, familiar with method transfer/qualification and validation requriements, analytical instrument qualification, calibration and maintenance, testing requriements for raw materials, components, pharmaceutical products and stability, OOS and deviation investigations, generation of QC documentation such as SOPs, computer skills with MS WORD, EXCEL, Power Point and Visio. Good interpersonal communication and written skills.
Please respond to b.ross(@)realstaffing.com if you would like to learn more about this specific role.Thank you for your interest.
To find out more about Real please visit www.realstaffing.com