senior Quality SpecialistRoche Pharmacutical Holding

Job Description
The Position
EssentialDutiesand Responsibilities includethefollowing (Other duties may be assigned):
LocalRegulatoryandSafetyOfficerEstablishesthelocalcasehandling process toassurequality and timelyexecution of productcomplaints and inquiries.
Conducts thetraining of the local personneloncomplaintsmanagement.
VerifiesthelocallyidentifiedPotentially Reportable Incident cases to ensureproperescalation to Global and conducts local assessment of PRI cases according to local laws includingreporting to authorities.
ManagesAffiliateNotificationsSafetyBoardNotifications(SBN) and QualityNotifications(QN)inaccordancewith MQMS.
Supportsother functions in themanagement of otheraffiliatenotifications
Performsproductrecallactivitiesrelatedtoqualityconcerns.
Liaise withall relevant associates to ensurethat any productssafetyissues are manage properly.
Collects and reports to RocheGlobalSafety all adverse eventsoccurring in affiliateandassociatedwithRocheproducts on an accurate and timelymanner.
Ensuresaccurate and timely submission to Health Authorities of all product safety related matters, if required.
SupportSSHE Officer for compliance of Roche DIAGNOSTICS to biosafety and other regulatory requirements
DeputyAffiliateQualityHead
Supports the AQH in ensuringthatthesite complies withapplicableDiagnosticsQualityStandards/ MQMS and localregulatoryrequirements such as:Trainingandcommunication,MonitoringofQ&RMetrics,AffiliateNotificationsandInternal/External audit, andSupplierQualification.
Informsaffiliate about new/updatedDiagnostics/Global SOP andthat, where applicable,these are incorporated into local procedures and all applicable staff is trained.
RegulatoryAffairsSupport
Preparesforand manages healthauthorityinspections by assuring theaffiliate is Operating in an inspectionreadymanner at all times.
Participates in industryassociation to keep abreast ofregulations and promoteRocheposition on regulatory issues.
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.