Job Description
● Monitoring laboratory instrumentation activities including procurement, qualification, preventative maintenance and calibration.
● Writing, reviewing, and revising Standard Operating Procedures (SOPs) as necessary.
● Writing procedures (SOP’s) which are in effect within the department and are compliant with current regulatory requirements.
● Overseeing all quality investigations within the department .
● Overseeing material specification, sampling, and qualification programs.
● Applying necessary oversight to the stability study program and ensure current regulatory guidelines are followed.
● Maintaining the department’s documentation practice compliance with cGMP and regulatory requirements.
● Developing the materials testing training program for QC analysts and lead the training activities.
