• To maintain and adherence of the GLP and safety procedures in laboratory. • To raise the request for issuance of formats, specifications and Test Methods. • To follow the instruction of In charge for planning. • To acquire training from concerned person to update the cGMP system update technical knowledge. • Preparation of SOP, CAPA closer note, Specification, Test Method, Analytical Report, Analytical Protocol, stability study Analytical Report and Stability study Analytical Protocol for Raw material, Packing Material, In-process, intermediate, Finished Drug substances and Recover solvents. • Raise change control and in laboratory and approve it in LIMS system. • Take all prints of document and checked from concerned section head then signed and make effective the document for use. • Provide training to all concern persons and provide Training tracker to QA for closing of change control. • Ensure CFR 21 part-11 compliance and follow the SOP/STP for analysis to maintain proper data integrity. • Ensure that all documents required for Regulatory Compliance are maintained properly. • To maintain the GLP and GMP practices & ensure standards procedures in Quality Control laboratory followed effectively. • To ensure awareness about the MSDS for concern persons. • To co – ordinate with cross function department for cGLP systems and its maintenance, up-dation. • To co – ordinate with EHS for safety and environment related activities and its management.
