QA & QC - Officer (Walk - in Drive)

Kopran

2 - 3 years

2 - 4 Lacs

Khopoli

Posted:3 hours ago| Platform:

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Skills Required

UV Formulation PH METER GC HPLC Karl Fischer FTIR Autotitrator Polarimeter

Work Mode

Work from Office

Job Type

Full Time

Job Description

QC Role & responsibilities

Handling of QC instruments, Such as HPLC, GC, UV, FTIR, Dissolution Apparatus, Melting point, Karl Fischer apparatus, Auto titration, Analytical weighing Balance, Polari meter, Disintegration Apparatus, pH Meter etc.
Analysis of In process, validation, Hold time study, finished products and stability samples according to related specifications
Daily as well as monthly calibration of analytical balance of instrumentation section
To maintain the daily logs adhering to the Good Laboratory Practices.
Daily standardization of Karl Fischer reagent.
Daily temp recording of instrumentation room, chemical room & refrigerator.
Daily preparation of 0.4% NaoH for discarded penicillin sample deactivation.
Regular, online analysis of cleaning (Rinse & swab) samples.

QA Role & responsibilities

Execute and review Equipment Qualification protocols (IQ, OQ, PQ) in compliance with regulatory requirements.
Prepare, execute, and review Cleaning Validation protocols and reports.
Participate in the design, execution, and documentation of Computer System Validation (CSV) as per GAMP 5 guidelines.
Coordinate and support Process Validation activities, including preparation and review of protocols, execution, and final reporting.
Ensure that all validation activities are compliant with cGMP, regulatory guidelines, and internal SOPs.
Perform gap assessments, risk assessments, and deviation handling related to validation.
Collaborate with cross-functional teams including production, engineering, QC, and IT for validation planning and execution.
Assist in internal audits, regulatory inspections, and prepare responses to audit observations.
Maintain and update validation master plans and SOPs regularly.

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