Manager

Found in: Talent AE A C2 - 2 weeks ago

Dubai, United Arab Emirates Marriott’ 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:
ReportsTo:LaboratorySystems Leader/ LaboratoryLeader

JobPurpose:Toexecute and appropriately document testing of Raw Materials,Intermediates, Drug Substance & Drug Product in accordancewith Analytical Standards and/or other approved protocols. Toprovide analytical support to product quality investigationsincluding the use of sophisticated analytical techniques. Toundertake significant assignments and to work on own initiative andwith minimum supervision e.g.technology transfer for new productdemonstrations; new methods development; management of an on-goingprogramme such as the Intermediate Stabilityprogramme;and to provide training for other chemists and other labstaff



RequirementsRoleFunctions:

1.The Laboratory Analyst has responsibility for Raw Material,Intermediate, Drug Substance & Drug Product testing to meetcompliance requirements and customer targets. The Analyst may alsotake a leadership role in change or improvement projects in ADC orat a sitelevel.
2.The Laboratory Analyst is responsible for ensuring all testingactivities comply with cGMP. The Laboratory Analyst assurescompliance with all safety and environmental requirements.Compliance with other regulated areas such as HR policies are alsoresponsibilities of therole.
3.To test Raw Materials, Intermediates, Drug Substance & DrugProduct in accordance with Analytical Standards and/or otherapprovedprotocols.
4.To comply with all GMP and analytical procedures relevant to areaofwork.
5.To adhere and comply with department High Performance AnalyticalBehaviours
6.To document all testing activities and to input results intocomputerised lab systems in accordance with department and MMDstandards.
7.To provide analytical support to product quality investigations andnew product demonstrations under the supervision of the LaboratoryLeader ordesignate.
8.Complete the investigation of laboratory OOSs (Z1 QualityNotifications), in line with site and divisional procedures, andProvide leadership in the laboratory aspects of OOSinvestigations.
9.Complete documentation checks (e.g. GCM s, Quality Notifications,Data Integrity) as required for test packages prior torelease.
10.To complete testing as required on non routine samples to supportprocess changes, Request for Service, QualityNotifications
11.Accountable for own laboratory safety practices. Follow theprinciples of Safe byChoice
12.To provide lead analytical support to product qualityinvestigations and new product demonstrations using own initiativeand with minimum supervision.13. To identify and aid resolution ofanalytical issues within the IPTlaboratory.
14.To be a resource for analytical testing for the site asrequired.
15.Execute specific assignments (e.g. DI Initiatives, Lab X Champion,Empower/LIMS Superuser and other systems) in a comprehensive mannerand under minimumsupervision.
16.Complete training with new laboratory Analysts and LaboratoryApprentices.

CoreCompetencies:

Technical:

To have demonstrated knowledge of MMD and site quality policies,procedures andguidelines

whichrelate to finished product testing andrelease.

Relevant GMPstandards

Lab safetystandards

Business:

To perform analytical testing with a high degree of precision andaccuracy

To perform instrument maintenance andtroubleshooting

To maintain accurate records in compliance with ALCOA principlesand GMPexpectations

To understand and internalise procedures relevant to GMPoperations

To communicate clearly and concisely on technicalissues

On assignment, to manage specific departmentprojects

To provide training programmes to laboratory staff asassigned

To liaise effectively with external groups such as MRL, RAS, DICOE,etc.

To act as auditee (in internal and external audits) for assignedareas ofresponsibility

Leadership:

Analytical chemistry demonstrated ability in all technical elementsrelevant to IPToperation
Technical lab skills (precision,etc)
Strong aptitude for handling analyticalinstruments
Clear understanding of DIrequirements
Mechanical andcomputer
Communication - written,oral
Team and interpersonalskills
Leadershipskills

SpecialFeatures:
  • Onassignment, and depending on experience, participates in or leadsdepartmental initiatives on improved compliance and qualitysystems.
    Operates as part of self-directed team inallocating testing and assigningpriorities.

EducationalRequirements:

  • Minimumof BSc in Chemistry or relateddiscipline.

#LI-AM1

Role Functions: 1. The Laboratory Analyst has responsibility forRaw Material, Intermediate, Drug Substance & Drug Producttesting to meet compliance requirements and customer targets. TheAnalyst may also take a leadership role in change or improvementprojects in ADC or at a site level. 2. The Laboratory Analyst isresponsible for ensuring all testing activities comply with cGMP.The Laboratory Analyst assures compliance with all safety andenvironmental requirements. Compliance with other regulated areassuch as HR policies are also responsibilities of the role. 3. Totest Raw Materials, Intermediates, Drug Substance & DrugProduct in accordance with Analytical Standards and/or otherapproved protocols. 4. To comply with all GMP and analyticalprocedures relevant to area of work. 5. To adhere and comply withdepartment High Performance Analytical Behaviours 6. To documentall testing activities and to input results into computerised labsystems in accordance with department and MMD standards. 7. Toprovide analytical support to product quality investigations andnew product demonstrations under the supervision of the LaboratoryLeader or designate. 8. Complete the investigation of laboratoryOOSs (Z1 Quality Notifications), in line with site and divisionalprocedures, and Provide leadership in the laboratory aspects of OOSinvestigations. 9. Complete documentation checks (e.g. GCM s,Quality Notifications, Data Integrity) as required for testpackages prior to release. 10. To complete testing as required onnon routine samples to support process changes, Request forService, Quality Notifications 11. Accountable for own laboratorysafety practices. Follow the principles of Safe by Choice 12. Toprovide lead analytical support to product quality investigationsand new product demonstrations using own initiative and withminimum supervision.13. To identify and aid resolution ofanalytical issues within the IPT laboratory. 14. To be a resourcefor analytical testing for the site as required. 15. Executespecific assignments (e.g. DI Initiatives, Lab X Champion,Empower/LIMS Superuser and other systems) in a comprehensive mannerand under minimum supervision. 16. Complete training with newlaboratory Analysts and Laboratory Apprentices. Core Competencies:Technical: To have demonstrated knowledge of MMD and site qualitypolicies, procedures and guidelines which relate to finishedproduct testing and release. Relevant GMP standards Lab safetystandards Business: To perform analytical testing with a highdegree of precision and accuracy To perform instrument maintenanceand troubleshooting To maintain accurate records in compliance withALCOA principles and GMP expectations To understand and internaliseprocedures relevant to GMP operations To communicate clearly andconcisely on technical issues On assignment, to manage specificdepartment projects To provide training programmes to laboratorystaff as assigned To liaise effectively with external groups suchas MRL, RAS, DI COE, etc. To act as auditee (in internal andexternal audits) for assigned areas of responsibility Leadership:Analytical chemistry demonstrated ability in all technical elementsrelevant to IPT operation Technical lab skills (precision, etc)Strong aptitude for handling analytical instruments Clearunderstanding of DI requirements Mechanical and computerCommunication - written, oral Team and interpersonal skillsLeadership skills Special Features: On assignment, and depending onexperience, participates in or leads departmental initiatives onimproved compliance and quality systems. Operates as part ofself-directed team in allocating testing and assigning priorities.Educational Requirements: Minimum of BSc in Chemistry or relateddiscipline. #LI- AM1

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