Engineering QMS- Pharma Company Bangalore location

From 3 to 6 year(s) of experience
₹ Not Disclosed by Recruiter

Job Description

Roles and Responsibilities

Dear Job seekers...................,,,

We are Hiring for A leading Pharma Company @ Bangalore location for the Position of Engineering QMS.

Job Profile:

Company: Pharma Company
Location: Bangalore
Position: Engineering QMS
Level: Executive to Sr. Executive
Qualification: B.E/B.Tech (Mechanical)/B.Pharma/ M. Pharma
Salary: 7 to 9 LPA

Contact person: Ms. Suma K S
9964523521
suma@bvrpc.com

Skills: QMS,QA

Job Summary:

ResponsibleforCompliance,QMSactivitiessuchasDeviationinvestigations,ChangeControls,
CAPA&Effectivenesschecks,temporarychanges,Training,RiskAssessments,SOP&Format
preparation,ImplementationofGSOPs,GapassessmentsandAuditrelatedactivities.Supportfor
engineering new projects and other activities as assigned

Job Responsibilities:

ExecuteallengineeringoperationasperestablishedARPLstandardsandprocedures.
EnsureandmaintainsafeworkplaceatARPLalltimeincoordinationwithEHSpersonnel.
CondutqualityofInvestigations.Initiations,implementationsandclosureofrelateddeviations,
CAPA’sofengineering.
PreparationandreviewofSOP’srelevanttoqualificationincludingperiodicrevisionand
complianceofengineeringSOPandtrainings.
Initiation,assessmentandclosureofengineeringandrelatedchangecontrols.
Conductimpactanalysisofproposedcorrective&preventativeactions.Discussesfindingswith
impacteddepartmentsandpreparerecommendationstoimplement.
MaintainandmonitorthequalificationstrategiesthroughtheValidationMasterPlantoensurethat
complianceandbusinessneedsareachived.
SupportforGMP/Regulatoryauditandpreparationofauditcompliancereport&ensureclosureof
auditobservations.
Preparationandreviewofriskassessments.
Followupwiththerespectivecrossfunctionalteamsforontimecompletionofdeviation/CCR/
CAPA/QMSactivities.
ReviewofBAS&BMStrendreports.
Reviewofallengineeringdocumentssuchasprotocols,Maintenanceworkorder/notification,
calibrationreport (Butnotlimitedto).
PeperationofGapassessmentsforassessingtheengineeringpracticeswiththeprocedures.
AttendtrainingsessionrelatedtocGMP,regulatorylatesttechnicalandindustrialdevelopments
relatedtoengineeringprojects.
Performallworkinaccordancewithestablishedregulatory,complianceandsafetyrequirements.
Worksinasafemannercollaboratingasateammembertoachievealloutcomes.
DemonstrateBehavioursthatexhibitourorganizationalValues:Collaboration,Courage,
Perseverance, and Passion.
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EnsurepersonaladherencewithallcomplianceprogramsincludingtheGlobalBusinessEthics
andComplianceProgram,GlobalQualitypoliciesandprocedures,SafetyandEnvironment
policies, and HR policies.
All other relevant duties as assigned.

Job Requirements:

Knowledge, Skills and Abilities
oHavegoodcommunicationknowledgeofEnglish(Speaking,ReadingandWriting).
oEnsureadherencetoprocedurevspractices,Gooddocumentationpracticesandensure
compliance.
oDemonstratedabilitytoworkeffectivelyasateammemberwithemployeesatalllevelsof
theorganization.
oHavingknowledgeinQMSdocumentation.
oHavingknowledgeinutilitiessystemsandequipment’s.
oHavingknowledgeinPreventivemaintenanceprocess.
oHands one Experience in Micro soft office, TrackwiseapplicationandSAP.
oHavingKnowledgeinCalibration,ThermalMapping,Qualificationanditsrelated
Documentation.
oHavinggoodinterpersonalandcommunicationalskills.
oHandsonISPE,ISOandWHOGuidelines.
oShallhaveexposuretoanyoftheregulatoryauditslikeUSFDA,MHRA,HC,TGA.Etc.,




Role:Mechanical Engineer

Salary: Not Disclosed by Recruiter

Industry:Pharmaceutical & Life Sciences

Functional AreaProduction, Manufacturing & Engineering

Role CategoryEngineering

Employment Type:Full Time, Permanent

Education

UG:B.Pharma in Any Specialization,B.Tech/B.E. in Mechanical

PG:M.Pharma in Any Specialization

Company Profile

BVR People Consulting

BVR people consulting committed to help Organisations to realise and develop their full potential in order to compete in the present day globalised and technology driven business environment. BVRPC invigorates the key components of organizations - ‘The People’ and ‘The Processes’. It is our endeavour to facilitate this process of ‘Rejuvenating Organisations’ through a variety of customised, innovative and practical solutions that bring about positive attitudinal shifts, while driving organisations to re-assess their true potential. These solutions are designed based on a thorough ‘Diagnosis’ and ‘Need Audit’ of the organisation. We work with our clients as partners and a team. Our solutions are tailored for each client's unique needs and business context, and are designed to ensure that clients get the best return on their investment.
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Recruiter Name:Suma K S

Contact Company:BVR People Consulting

Telephone:9964523521

Website:http://careers.bvrpc.com