About this role
Major Purpose of the Job
Monitoring and assure effective functioning of Quality Control Laboratory.
Principal Tasks:
To ensure effective review of analytical reports and approval of all analytical/microbiological reports.
Approval and rejection of Raw material, Packaging material, Finished Goods and Stability
Maintain the cGLP in Quality Control Lab.
To maintain quality control documents as per statutory requirements.
Responsibilities:
To ensure effective review of analytical reports and approval of all analytical/microbiological reports.
Formal investigation of out-of-specification, incidents out-of-trend test results and errors and documentation of investigation, including action taken.
Updation of method as per current GLP guidelines and regulatory requirements.
Review / Approval of LIMS results entry done by analysts.
Review and approval of protocols for different studies like temperature distribution study, glassware/accessories cleaning validations, software validation/verification etc.
Review and approval of specification for input materials, intermediates, active pharmaceutical ingredients, finish products and stability products to ensure compliance with compendia and company standards.
To ensure analysis and compliance of raw materials, packing materials, finished products, Microbiology and stability samples released with intended specifications and regulatory or customer requirements.
Training of analyst in Laboratory techniques, Quality Control Procedures and principles of Good Laboratory Practice/ General analytical methods/Instrumentations.