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About PSCBiotech

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.

JobDescription:
Thisposition within the QA department will provide Quality oversight,support and knowledge to activities relating to Quality Systemsacross the site and in meeting the client s priorities of:Compliance, Supply, Strategy and Profit Plan.

The team working style is one ofcollaboration, coaching and facilitation to ensure the success ofthe site. The Associate Quality Specialist is accountable for theQuality Systems within the site.

This rolerequires the delivery of a robust Quality Management System tosupport a flexible, collaborative, multi-skilled teamworkenvironment.

The Quality Specialist willhave proven capability in development of Quality Systems as anactive member, across cross functional teams, to deliver processimprovement. The Quality Specialist will model the client sLeadership behaviours and understand the MPS principles to drive aculture of continuous improvement building a High-PerformanceOrganisation.

The Quality Specialist willparticipate and comply with the client s Quality Management System(QMS) requirements, including ownership.

Requirements

Primaryactivities/responsibilities:

• Providesto the site knowledge and experience in Quality Systems.
  
• Usesknowledge to improve Quality Systems, solve problems, providecontinuous improvement, and executetasks.
  
• Providescompliance contribution to project teams and leads smallprojects.
  
• Coachesand guides colleagues within thesite.
  
• Understandsand applies regulatory / compliance requirements to their roletogether with remaining current on upcoming regulatory andcompliancechanges.
  
• Respondsto non-standard requests from customerneeds.
  
• Makesdecisions within guidelines and policies which impact ownpriorities and allocation of time to meetdeadlines.
  
• SupportsCorporate Quality to ensure actions related to Quality Systems atthe site areexecuted.
  
• Participationin inspections of Site by Divisional / Regulatory Bodies / thirdparties together with follow up actions whereapplicable.
  
• Participationin and leading internalinspections
  
• Participatein GMPWalkthroughs.
  
• Managesupplier agreements and supplymaps
  
• DeviationManagement & Change Controlapproval.
  
• Ensuressupply of high-quality product through the implementation andoversight of the Quality Management System for thesite.
  
• Championthe highest Quality and Compliance standards for thesite.
  
• Ensurehighest safetystandards.
  
• Additionalactivities as requested by QALead
  

Required:

• Degreeor 3rd level qualification (Science, Quality).
  
• Demonstratedknowledge in more than one pharmaceutical and/or chemicalmanufacturing operation
  
• 5 yearsexperience in the Pharmaceutical industry or a similar operatingenvironment which includes experience in a Qualityfunction
  
• QualityAssurance SME knowledge, from both operational and educationalexperience, is required
  
• Knowledgeand experience in interpreting current regulatory requirements andproviding independent support to thesite
  
• Demonstratedability to work independently and fully realize improvementinitiatives with a moderate level ofguidance
  
• Demonstratedability to work and succeed within teams as well as leading smallprojectteams.
  
• Demonstratedability to drive the completion oftasks.
  
• Proventrack record of providing independent Quality support to thesite.
  
• AdvancedPC skills such as Excel, Word,PowerPoint.
  
• Stakeholdermanagement of multiple decision makers, auditors, cross functionalteams by demonstrating the ability to maintain and strengthen trustrelationships with people on alllevels.
  
• Provendecision-making capability with full accountability andresponsibility.
  
• Energeticwith proactive & positiveattitude.
  
• Demonstratedcoachingskills.
  
• Demonstratedability to solveproblems.
  

Desired:

• Desirableevidence of Continuous ProfessionalDevelopment.
  

#LI-SO1

Primary activities/responsibilities: Provides to the site knowledgeand experience in Quality Systems. Uses knowledge to improveQuality Systems, solve problems, provide continuous improvement,and execute tasks. Provides compliance contribution to projectteams and leads small projects. Coaches and guides colleagueswithin the site. Understands and applies regulatory / compliancerequirements to their role together with remaining current onupcoming regulatory and compliance changes. Responds tonon-standard requests from customer needs. Makes decisions withinguidelines and policies which impact own priorities and allocationof time to meet deadlines. Supports Corporate Quality to ensureactions related to Quality Systems at the site are executed.Participation in inspections of Site by Divisional / RegulatoryBodies / third parties together with follow up actions whereapplicable. Participation in and leading internal inspectionsParticipate in GMP Walkthroughs. Manage supplier agreements andsupply maps Deviation Management & Change Control approval.Ensures supply of high-quality product through the implementationand oversight of the Quality Management System for the site.Champion the highest Quality and Compliance standards for the site.Ensure highest safety standards. Additional activities as requestedby QA Lead Required: Degree or 3rd level qualification (Science,Quality). Demonstrated knowledge in more than one pharmaceuticaland/or chemical manufacturing operation 5 years experience in thePharmaceutical industry or a similar operating environment whichincludes experience in a Quality function Quality Assurance SMEknowledge, from both operational and educational experience, isrequired Knowledge and experience in interpreting currentregulatory requirements and providing independent support to thesite Demonstrated ability to work independently and fully realizeimprovement initiatives with a moderate level of guidanceDemonstrated ability to work and succeed within teams as well asleading small project teams. Demonstrated ability to drive thecompletion of tasks. Proven track record of providing independentQuality support to the site. Advanced PC skills such as Excel,Word, PowerPoint. Stakeholder management of multiple decisionmakers, auditors, cross functional teams by demonstrating theability to maintain and strengthen trust relationships with peopleon all levels. Proven decision-making capability with fullaccountability and responsibility. Energetic with proactive &positive attitude. Demonstrated coaching skills. Demonstratedability to solve problems. Desired: Desirable evidence ofContinuous Professional Development. #LI-SO1