QC Analyst

Syngene

1 - 3 years

3 - 5 Lacs

bengaluru

Posted:Just now| Platform:

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Skills Required

ehs accessories chemical analysis lms microbiology formulation packaging manager quality control gmp monitoring

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsible for Water sampling, Sample receipt of raw materials, in process, finished product and stability samples.

Responsible for Chemical analysis of different grades of water (PW/WFI/POW) as per the respective specification.
Responsible for sample management and coordination with team for smooth operation of samples release activity.
Monitoring and review of Temperature monitoring data record of equipment and clean room. Monitoring of differential pressure in Laboratory.
Analysis of Raw Material/ In process samples/ cleaning samples/ Intermediate samples/Finished product/water sample / Packaging materials/ Formulation finished products and management/traceability of Reserve samples and Visual inspection samples.
Maintenance of sampling tools as per the standard operating procedure.
Carry out the analysis on the qualified techniques as per the approved specification / protocol / procedures and interpret the data from analytical instruments and report the results and submit the completed documents for review promptly.
Preparation for Certificate of analysis
Recording of analytical observations/ findings, reporting of data and results in observation data sheets, forms, logbooks, LIMS and ELN application software
Reporting of any abnormal observation identified during analysis to reporting manager/Group leader/HOD immediately.
Creation/ preparation of documents, master data/ static data creation in LIMS, ELN and LMS Software as applicable.
Initiation of QMS elements and other documents in Track wise and EDMS application software.
Coordination with engineering maintenance and external vendor for preventive maintenance and calibration activity.
Initiation of Change control, CAPA, deviation, Laboratory Incident, OOS, OOT, Non-Conformity as applicable.
Disposal of left-over Sample after review/approval of analytical report /Release.
To indent the chemicals, glassware, document, instrument, and accessories required for performing analysis as per the plan.
Archive and retrieve documents related to the section.
Adherence to Good Laboratory Practice and Good documentation practices.
Cleaning of workplace and following Good Laboratories Practices while working in QC Laboratory.
Individuals working in the GMP environment are responsible for documenting/recording the activities contemporaneously and accurately as per Good documentation practices.
Handling of LMS, LIMS, ELN, Track Wise and EDMS Software for routine activities as applicable.
Receipt, Inventory management, Qualification, Labeling, Dispensing of Analytical standards, removal and disposal of expiry standards and Storage of standards as per the appropriate storage condition used in Quality Control Laboratory.
Review the status of Pharmacopoeia reference standards and their validity periodically.
Preparation of Standard Qualification protocol, Report and COA as applicable.
Responsible for disinfectant preparation, cleaning, and fumigation of microbiology laboratory.
Follow the required EHSS policies and good hygiene practice.
Responsible for taking any other job allocated by HOD / Group Leader/Section Head/ Section In-Charge.

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