Admin Assistant

2 weeks ago

Doha, Baladīyat ad Dawḩah, Qatar AM Business Hub W.L.L. 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.


RoleDescription:


TheQuality Specialist will perform an integral role in the CarlowEngineering team .They will work within a small team that will bemainly responsible for compliance aspects within the EngineeringCoE team. This will include but not limited to the completion ofinvestigations, generation and management of change controls andsupporting the IFM Compliance and EHS Engineer asrequired.



RequirementsRoleFunctions:

SupportEngineering activities through documentation generation, equipmentand process investigations associated with GMP activities andcompletion of qualitynotifications.
Bea document system expert; this will include document review,approval and document system work flow expedition. Format, write,deliver and review necessary documentation in line with thestandard approval process, and facilitate others to do so.Documents will include SOP s, SWI s, training documents, and changecontrols.

Experience,Knowledge &Skills:

RaiseCAPAs and conduct investigations. Raise and investigate qualitynotifications using standard tools and methods, to resolve systemissues e.g. FMEA, Fishbone diagrams, 5 why s etc.; implementsubsequent corrective action through the change managementsystem.
Requiredto comply with client s Global Policies, Procedures and Guidelines,regulatory requirements and execute current Good manufacturingPractices (cGMP) in the performance of day to day activities andall applicable jobfunctions.
Supportand lead Internal Quality audits of EngineeringDept.
Assistin the management and/or assignment of Engineering training ifrequired
Workcollaboratively to drive a safe and compliant culture inCarlow.
Maybe required to perform other duties asassigned.
REPORTINGSTRUCTURE
CarlowAssociate Director, EngineeringCoE

General

  • Demonstratingenergy and enthusiasm, the Quality Specialist, will be a role modelfor operational excellence, and will contribute to the departmentsoverall capability to thrive and grow.
  • Proventrack-record in delivering results in a world-class supplyorganisation.
  • Astrong career history in pharma (ideally working in a cleanutilities and/ or compliance environment) and familiarity with ahighly regulatedenvironment.
  • Innovativethinker, with excellent decision-making and problem-solvingskills.
  • Experienceof working in a cross functionalenvironment.
  • Knowledgeof and experience in applying Six Sigma and Leanmethodologies.
  • Positive,flexible action-orientedattitude.

Technical

Experiencein Compliance systems such as IPI, SAP etc a distinctadvantage

  • Knowledgeof regulatory/code requirements to Irish, European andInternational Codes, Standards andPractices
  • Report,standards, policy writing skillsrequired
  • Proficiencyin Microsoft Office and job related computer applicationsrequired
  • LeanSix Sigma Methodology experiencedesired

Experienceworking within an Engineering environment in a regulated industry adistinctadvantage

People
Thedesire to continuously learn, improve anddevelop.
Excellentcommunication, presentation and interpersonal skills, to interfaceeffectively with levels of colleagues and with external customersin a team orientatedmanner
Excellenttraining, facilitation and assessmentskills
Demonstrableanalytical and systematic problem solvingskills
Stronginfluencingskills
Flexibleapproach
Effectivetime management and multi-taskingskills
Provenorganizationalskills
Excellentattention todetail
Troubleshootingskills
Goal/resultsorientated

Education:
  • Degreequalification or equivalent Min Level 7 (Science, Engineering,Technical).
#LI-AP1

Role Functions: Support Engineering activities throughdocumentation generation, equipment and process investigationsassociated with GMP activities and completion of qualitynotifications. Be a document system expert; this will includedocument review, approval and document system work flow expedition.Format, write, deliver and review necessary documentation in linewith the standard approval process, and facilitate others to do so.Documents will include SOP s, SWI s, training documents, and changecontrols. Experience, Knowledge & Skills: Raise CAPA's andconduct investigations. Raise and investigate quality notificationsusing standard tools and methods, to resolve system issues e.g.FMEA, Fishbone diagrams, 5 why s etc.; implement subsequentcorrective action through the change management system. Required tocomply with client s Global Policies, Procedures and Guidelines,regulatory requirements and execute current Good manufacturingPractices (cGMP) in the performance of day to day activities andall applicable job functions. Support and lead Internal Qualityaudits of Engineering Dept. Assist in the management and/orassignment of Engineering training if required Work collaborativelyto drive a safe and compliant culture in Carlow. May be required toperform other duties as assigned. REPORTING STRUCTURE CarlowAssociate Director, Engineering CoE General Demonstrating energyand enthusiasm, the Quality Specialist, will be a role model foroperational excellence, and will contribute to the departmentsoverall capability to thrive and grow. Proven track-record indelivering results in a world-class supply organisation. A strongcareer history in pharma (ideally working in a clean utilities and/or compliance environment) and familiarity with a highly regulatedenvironment. Innovative thinker, with excellent decision-making andproblem-solving skills. Experience of working in a cross functionalenvironment. Knowledge of and experience in applying Six Sigma andLean methodologies. Positive, flexible action-oriented attitude.Technical Experience in Compliance systems such as IPI, SAP etc adistinct advantage Knowledge of regulatory/code requirements toIrish, European and International Codes, Standards and PracticesReport, standards, policy writing skills required Proficiency inMicrosoft Office and job related computer applications requiredLean Six Sigma Methodology experience desired Experience workingwithin an Engineering environment in a regulated industry adistinct advantage People The desire to continuously learn, improveand develop. Excellent communication, presentation andinterpersonal skills, to interface effectively with levels ofcolleagues and with external customers in a team orientated mannerExcellent training, facilitation and assessment skills Demonstrableanalytical and systematic problem solving skills Strong influencingskills Flexible approach Effective time management andmulti-tasking skills Proven organizational skills Excellentattention to detail Trouble shooting skills Goal/results orientatedEducation: Degree qualification or equivalent Min Level 7 (Science,Engineering, Technical). #LI- AP1

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