Senior Manager

1 month ago

Dubai, United Arab Emirates Chalhoub Group Full time
PSCBiotech provides the life sciences with essential services toensure that health care products are developed, manufactured, anddistributed to the highest standards, in compliance with allapplicable regulatory
Ourgoal is to skyrocket our clients success, and you can be a part ofour team s Employing a global team of skilled professionals andexperts that span across strategically located offices in NorthAmerica, Europe, Asia and the Middle East, we are proud of theroles we have fulfilled to help our clients achieve

TheExperience

Withoperations spanning the globe and featuring a multi-cultural team,PSC Biotech is passionate about bringing the best and brightesttogether in an effort to form something truly When you make thedecision to join our team, you will be offered the ability to feelinspired in your career, explore your professional passions, andwork alongside a group of people who will value and nurture your

Weare firm believers in coaching and developing the next generationof industry leaders and As such, you will not only be offeredcompensation and benefits structure that rewards you, but also beprovided with the tools that will help you grow and

AtPSC Biotech , it s about more than just a job it s about yourcareer and your

YourRole

Weare looking for a Commissioning, Qualification, and Validation(CQV) The CQV Professional would work alongside a talented PSCBiotech Team in an exciting, developing and diverse biotechnology
  • Commission,qualify, and validate GxP facilities, process and laboratoryequipment and utilities in assigned
  • ProvideCQV authoring, review and approval of validation documentsdeveloped by functional validation teams, ensuring thedocumentation meets regulatory requirements and quality
  • Draftand execute validationdocumentation:
    • ValidationProjectPlan
    • RequirementSpecification (URS, DS,FS)
    • IQand OQ TestScripts
    • IQ/OQ/PQProtocols, asnecessary
    • ValidationSummaryReport
  • Developrisk assessments associated with validation
  • Executeprocess equipment and clean room
  • Writereports summarizing system
  • Clearlycommunicate all progress, updates, and action steps for assigned


Requirements
  • BachelorsDegree in a relevant science or engineering field, or equivalentyears of hands-on
  • 3+years experience in the biotechnology and pharmaceutical industrieswith a minimum of 2 years relevant experience performing CQVactivities within GMP
  • Soundindustry knowledge, project proficiency, and autonomy;
  • Experiencedin CQV of facility/utility/equipment, including PW, HVAC andprocess or laboratory equipment,
  • Understandscurrent risk-based validation
  • Experiencein authoring, revising, reviewing, and completing controlleddocuments for validation
  • Experiencewith system impact assessment and risk
  • Goodknowledge of the code of GMP and PIC/S
  • Previousexperience in the Life Sciences Industry is
  • Previousexperience in GxP Industries are
  • Mustbe adaptable, customer service oriented, have a positive
  • Excellentorganizational
  • Highattention to
  • Musthave strong written and verbal communication



BenefitsEqualOpportunity Employment Statement:
PSCis committed to is committed to a policy of Equal EmploymentOpportunity with respect to all employees, interns, and applicantsfor Consistent with this commitment, our policy is to comply withall applicable federal, state and local laws concerning employmentAccordingly, the Company prohibits discrimination against qualifiedemployees, interns and applicants in all aspects of employmentincluding, but not limited to: recruitment, interviewing, hiring(or failure or refusal to hire), evaluation, compensation,promotion, job assignment, transfer, demotion, training, leaves ofabsence, layoff, benefits, use of facilities, working conditions,termination and employer-sponsored activities and programs,including wellness, social and recreational Employment decisionswill be made without regard to an applicant s, employee s, orintern s actual or perceived: race, color, religion, sex (includingpregnancy, gender identity, and sexual orientation), nationalorigin, age (40 or older), disability, genetic information, or anyother status protected by

#LI-AK1

Bachelor's Degree in a relevant science or engineering field, orequivalent years of hands-on 3+ years experience in thebiotechnology and pharmaceutical industries with a minimum of 2years relevant experience performing CQV activities within GMPSound industry knowledge, project proficiency, and autonomyExperienced in CQV of facility/utility/equipment, including PW,HVAC and process or laboratory equipment, Understands currentrisk-based validation Experience in authoring, revising, reviewing,and completing controlled documents for validation Experience withsystem impact assessment and risk Good knowledge of the code of GMPand PIC/S Previous experience in the Life Sciences Industry isPrevious experience in GxP Industries are Must be adaptable,customer service oriented, have a positive Excellent organizationalHigh attention to Must have strong written and verbalcommunication

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