Junior Scientist - Quality Assurance

Job Overview

Location
Mysore/Mysuru, Karnataka
Job Type
Full Time
Salary
₹30,000 - ₹45,000 Per Month
Date Posted
1 month ago

Job Description

· Responsible to perform testing of raw materials, in-process and finished drug-device combinations, and devices that are commercially manufactured by the company according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs). Comply with CGMP's, SOP's, and STP's to avoid out-of-specification situations.

· Perform testing of raw materials, in-process and finished drug-device combinations, and devices that are in the NPD and Regulatory Phase. This includes Drug Loading. Elution Kinetics and Shelf-LifeStudies.

· Perform stability studies, cleaning verification following written procedures and applicable SOPs, calculate and report results on applicable specification documents, participate in method transfer activities within departments or between facilities or organizations.

· Provide feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture.

· Assure compliance with state and federal regulations. Actively participate in any project work as and when assigned. Perform process validation and cleaning validation/verification testing on various drug-device combinations and devices. Operation & troubleshooting of all sophisticated Instruments and assisting other scientists with the analytical, instrument, and software-related problems as required. Calibrate HPLC, HBLT, Universal Tensile testing machine, PH meters, analytical balances, and other laboratory equipment. Document steps followed during analysis execution, calculate, and report results. Actively participate in the investigation of laboratory results.

· Review laboratory analysis data for completeness, specification compliance, and compliance with the company's written policies. Report any abnormal findings to the supervisor. As assigned, perform an in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications.

· Preparation and review of QMS documents as per ISO 13485 standards and supervising the implementation of the QMS.

· Ensuring Compliance with Standard Testing Procedures and Specifications.

· Sampling and Analysis of Materials for their parameters as per Standard Testing Procedure and specifications

· Maintenance of logbooks and other related records as per regulatory norms.

· Supporting all QC activities and Proactive Quality improvements.

Candidate Profile & Pay Package

· M. Pharmacy/ B. Pharmacy/BE/ M. Sc - Chemistry, Organic Chemistry with 0-2 years of experience in Quality control and handling of analytical instruments.

· HPLC handling is more desirable.

· CTC 4.8 Lakhs to 5.4 Lakhs per annum. Eligible for Company project incentive on successful completion of Probation.

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