Quality urance Specialist

3 weeks ago

Abu Dhabi, Abu Dhabi, United Arab Emirates Oscar Full time
AboutPSCBiotech

Whoweare?

PSCBiotech is a leading Biotech Consultancy firm founded in 1996,headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350clients in more than 23 countries worldwide. We provide cloud-basedsoftware solutions for Quality Management and RegulatoryInspections, pharmaceuticals contract manufacturing professionals,and metrology services to ourclients.


Take your Career to a new Level

PSCBiotech disrupts the conventional consultancy model by aligning ourEVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-mindedprofessionals operating in the Pharma/ Biotech Industry. We offer apermanent contract of employment giving exposure of working in TopPharmaceutical client sites in a diverse-cultural worksetting.


EmployeeValueProposition

Employeesare the heartbeat of PSC Biotech, we provide unparalleledempowering career development though Learning & Developmentin-house training mentorship through constant guidance tofacilitate career progression. We believe in creating highperforming teams that can exceed our client s expectations withregards to quality of all scalable and business unit deliverables,staying under budget and ensuring timelines for our deliverablesare beingmet.



TheQuality Specialist is responsible for supporting the developmentand maintenance of the Pharmaceutical QualitySystem.

Additionally,this role will manage and oversee critical quality system elementspertained to supplier management, product dispositions, deviations,change control, CAPA and support Quality ManagementReview.

Support theday-to-day quality systems for allproducts

Provide Qualityoversight of clinical, commercial, distribution, and drugsafety/pharmacovigilanceactivities

Oversee DocumentControl, Deviations, CAPA, Change Control, Complaints, Training andMetrics

Partner withSupply Chain, Regulatory Affairs, Tech Services and Management toensure compliance with policies, procedures, and industryregulations

Provide ContractManufacturing Organization (CMO) QualityOversight

Support theevaluation of product quality complaints, investigations andassociated CAPA(s) for potential reportableevents

Supportthird-party supplier/CMOinvestigations

Facilitate theDocument ControlSystem

Support theadministration of eQMSsystem

Facilitate thethird-party change controlsystem

Support thedevelopment and Management of the trainingprogram

Organize andpresent metrics for management review meetings and QualityCouncil

Support internaland external audits asneeded

Assist as neededin the drafting of QualityAgreements

Participate ininternal and external meetings and site visits to ensure cGxPcompliance

Buildrelationships with Quality partners at CMOs to resolve qualityissues in a timelymanner

Compile andprovide documentation and responses to Regulatory and Compliancerequests (GMP renewals, RA questions and submissions, observations,compliance gaps,audits)

Support thecompilation of Annual Product QualityReviews

Engage inactivities to continuously assess and improveprocesses

Support theassessment, implementation, and management of Risk ManagementProgram

Other duties asrequired or directed by QAManagement

Support theSupplier Qualification program including, but not limited to:maintaining the Approved Supplier List in state of compliance,schedule, assign and conducts external audits, including issuing ofaudit reports and conducting follow-ups asappropriate



Requirements

Bachelors degree in a scientific discipline ispreferred

Minimum of 3-5+years of progressive experience in a GMP environmentrequired.

Minimum of 3-4year of Quality Assurance experience in support of GMP productionrequired.

Workingknowledge of GMPs and their application to pharmaceuticalmanufacturingrequired.

Previousexposure to investigations and product complaintspreferred.

Must be able tointerpret applicable standards and objectively make decisions withsupport ofmanagement.

Must beproficient in MS OfficeSuite.

Experience inthe use of Material Requirements Planning (MRP) systemspreferred.

Excellentorganizational and communication (oral and written)skills

Experience withthe application of GDPs within the pharmaceuticalindustry

Familiarity withthe manufacturing and packaging process of solid oral dosage andliquid drugproducts

Experienceworking with external partners in a Quality Assurancecapacity

High level offlexibility and willingness tolearn

Ability to workin a high paced, timeline driven corporate officesetting


#LI-AP1

Bachelor s degree in a scientific discipline is preferred Minimumof 3-5+ years of progressive experience in a GMP environmentrequired. Minimum of 3-4 year of Quality Assurance experience insupport of GMP production required. Working knowledge of GMPs andtheir application to pharmaceutical manufacturing required.Previous exposure to investigations and product complaintspreferred. Must be able to interpret applicable standards andobjectively make decisions with support of management. Must beproficient in MS Office Suite. Experience in the use of MaterialRequirements Planning (MRP) systems preferred. Excellentorganizational and communication (oral and written) skillsExperience with the application of GDPs within the pharmaceuticalindustry Familiarity with the manufacturing and packaging processof solid oral dosage and liquid drug products Experience workingwith external partners in a Quality Assurance capacity High levelof flexibility and willingness to learn Ability to work in a highpaced, timeline driven corporate office setting
Key Skills
LeadershipSkill
Employment Type : FullTime
Department / Functional Area: Quality,Testing,QA,QC,Inspector
Experience: 6 Years - 8 Years years
Vacancy: 1
Joining Date: Tue, 11Feb 2025

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