Job Description
- Testing and release of Raw material, packing material and miscellaneous material samples.
- To maintain reserve sample as per SOP.
- Preparation of specifications of raw materials, packing material, in process and finished products and stability protocol as per requirement.
- Preparation of study protocols with respect to laboratory.
- Sampling of Raw material, packing material and miscellaneous material samples and maintain reserve sample as per SOP.
- Preparation of volumetric solutions, reagent solution, working standards and maintain records.
- To perform water analysis as per specification, SOP and GTP.
- To maintain daily water analysis trend record.
- To prepare and maintain Laboratory reagent and volumetric solution as per SOP.
- To keep neat and cleanliness at workplace and follow the good laboratory practices in the laboratory.
- Testing and release of in process, finished product, standards, and stability samples.
- To keep update of instruments logbooks and to record the data in Laboratory Notebook during testing.
- To perform the calibration, Maintenance of all instruments/equipment’s as per respective schedule.
- To attain and complete self- training record.
- Preparation of indents as per the materials/product requirements.
- To prepare COA of various product/material as per requirement whenever required.
- Responsible to share the login credentials with new joiners.
- To ensure that employees in the department are trained as per the function mapping before work.
- To upload training copy of new/ revised SOP
- To ensure training and training related activities for the Department.
- To ensure the regular updating of Ad hoc/Classroom training details in training software.
- To generate re-training of any SOP for an employee/s as and when required
- Submit the employee training files to training cell in case any employee left or no longer with the organization.
- Responsible as a Department training coordinator (DTC) for the QCC Department
- Initiate AIMS Requisition for creation, modification, removal, addition, or employee inactivation in AIMS Software.
- Preparation and review of QC related SOPS.
- Preparation of general test procedures, method of analysis, specification as per requirement of raw material and packaging material.
- To initiate and review of A) Change controls B) Out of specifications C) Deviations
Qualifications
Education: B.Sc., M.Sc., B.Pharma,
Total Experience - 2 - 7 Year in QC department of sterile manufacturing plant
Note: Candidates who want to apply for internal jobs, must have completed atleast 2 years within existing role.
