Senior Executive, Quality Control (QCC)

Amneal Pharmaceuticals

Date: 3 weeks ago

City: Ahmedabad, Gujarat

Contract type: Full time

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.

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