Associate Director - Glasgow, United Kingdom - FPSG Connect

FPSG Connect

Verified Company

Glasgow, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Role responsibilities:

Legal responsibility for QC for manufacturing and manufacturing directed release testing
Assess and advise on release specifications and / or reject raw materials Evaluation of batch records to perform QP release of interim Drug Substance
Approve and monitor internal and contract analysis testing
Approve characterization and release testing on manufacturing specifications
Ensure that out of specifications (OOS) and deviations are appropriately investigated and resolved
Ensure all manufacturing directed testing and Product testing is performed accurately and appropriately.
Review and approve assay validation protocols and reports
Participate in continuous improvement projects (Local and Global)
Prepare appropriate Standard Operating Procedures (SOP) and training modules when required and carry out the training.
Be a member of onsite management team and attendance at leadership meetings (Local and Global)

Who you are:

Degree, or equivalent, in relevant life science. Advance degree preferred
Eligible to be a permanent Qualified Person for commercial and Investigational products
Extensive handson experience in Quality Control
Proven experience at a senior level leading a QC function in a life science GMP/FDA regulated environment, such as pharmaceutical and biopharmaceutical devices and diagnostics.
Experience with common continuous improvement tools sigma).
Extensive knowledge of EU/US GMP/GLP and related standards
Technical experience of a wide range of biological testing techniques
Proven ability to lead change through an organization
Commercially aware
Knowledge of Quality Risk Management.