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Quality Control - Sany, India - Miracle Hub
Description
Quality Control PharmaFormulation
RequiredQuality ControlAnalyst
Location:
Ankleshwar GujaratIndia
IndustryPharmaFormulation
Musthave 35 Years of Experience (Must be from FormulationIndustry)
JobDescription:
Asa Quality Control Analyst in pharmaceutical manufacturing you willplay a vital role in ensuring the quality purity and safety of rawmaterials intermediate products and finished pharmaceuticalproducts.
KeyResponsibilities:
AnalyticalTesting:
Perform a variety of analytical tests on raw materialsinprocess samples and finished products using laboratory equipmentsuch as HPLC GC UVVis spectrophotometer dissolution apparatus andother instruments.
Conduct tests to assess chemical compositionphysical properties and microbiologicalattributes.MethodDevelopment and Validation:
Develop and validate analytical testmethods for the analysis of pharmaceutical products in accordancewith regulatory guidelines and industry standards. Optimize methodsfor accuracy precision sensitivity and specificity and ensurecompliance with validationrequirements.
SamplePreparation:
Prepare samples for analysis by following establishedprocedures for sample collection extraction dilution andfiltration. Ensure proper handling and storage of samples toprevent contamination degradation or loss ofintegrity.
DataAnalysis and Interpretation:
Analyze test results and interpretdata to assess product quality compliance with specifications andadherence to regulatory requirements. Identify deviationsoutofspecification (OOS) results and trends and communicatefindings to relevantstakeholders.
InstrumentCalibration and Maintenance:
Perform routine calibrationmaintenance and troubleshooting of laboratory equipment to ensureaccuracy reliability and compliance with regulatory requirements.
Document instrument performance and maintenance activitiesaccording to establishedprocedures.
Documentationand Recordkeeping:
Maintain accurate and uptodate records ofanalytical testing activities including test results laboratorynotebooks instrument logbooks and electronic data records. Ensurethat all documentation is complete legible and traceable for reviewand auditpurposes.
ComplianceOversight:
Ensure compliance with current Good ManufacturingPractices (cGMP) regulatory guidelines and company policies andprocedures. Participate in internal and external audits inspectionsand quality assessments and implement corrective actions asneeded.
QualityControl Review:
Review and approve analytical test data laboratoryreports and quality control records generated by other analysts ortechnicians. Verify the accuracy and completeness of data anddocumentation before release for further processing or productrelease.
ContinuousImprovement:
Identify opportunities for process improvementefficiency gains and cost savings within the quality controllaboratory. Participate in quality improvement initiatives rootcause investigations and CAPA implementation to enhance overalllaboratoryperformance.
Qualifications:
Bachelors or Master s degree in Chemistry Pharmaceutical SciencesAnalytical Chemistry or relatedfield.
Previous experience in apharmaceutical quality control laboratory preferably in acGMPregulated environment.
Proficiency inanalytical techniques and instrumentation including HPLC GC UVVisspectrophotometry and dissolutiontesting.
Strong understanding of cGMPregulations regulatory guidelines (e.g. FDA ICH) and qualitymanagement systems.
Excellent attention todetail organization and time managementskills.
Strong problemsolving andtroubleshooting abilities.
Effectivecommunication and interpersonal skills with the ability to workcollaboratively in a teamenvironment.
Proficiency in MS Officeapplications and laboratory information management systems(LIMS).
qualitycontrol,compliance,formulation,testing,documentation,regulatoryguidelines,maintenance
