Purpose:
The positions will be based in the MSAT laboratory as part of the Foreign Matter Team. The team members will be responsible for isolating particles from sterile biologics and informing the investigation as to the origin on the particle. Specifically, FTIR, Scanning electron microscopy, RAMAN spectroscopy.
Responsibilities:
* Provide analytical chemistry services and support to Site.
* Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases. In particular, close contact maintained with Quality Assurance Production, Engineering and Planners.
* Maintain, update and issue chemical methods, specifications and SOP's in compliance to pharmacopoeial and regulatory requirements.
* Assist with training of the analysts in areas of expertise and
* knowledge and in new methods, SOP's and updates.
* Trend such results, record on COA's where required and complete OOS's investigations on a timely basis.
* Update the QC Team Leader on potential problems and highlight improvements where possible by use of the normal communication means.
* Ensure all quality documentation and records are complete and current
* Ensure QC laboratories meet current Good Laboratory Practice (cGLP) requirements.
* Ensure relevant procedures are correctly defined and followed
* Ensure that critical chemical testing and related equipment meets current validation requirements (IQ, OQ, PQ) where required.
* Audit and review chemistry test results on a daily basis and ensure compliance with cGLP.
* Checking/auditing laboratory notebooks and analytical reports
* Ensure compliance to cGMP at all times