Manager - Sterility Assurance

Julphar
United Arab Emirates
Workplace: OnsiteFull timeFunction: Quality & Regulatory (Non-Software)Experience: 10+ yearsEducation: bachelorsSkills: ["Ownership","Accountability","Coaching","Training","Quality focus"]

Lead end-to-end quality oversight for sterile pharmaceutical manufacturing, including batch certification and release as the Qualified Person (QP). Ensure cGMP and QMS compliance across sites by monitoring documentation, environmental conditions, calibrated/qualified equipment, deviations/investigations, CAPA, and change control. Own product lifecycle quality activities (PPQ, CPV, stability, APQR/PQR trends), conduct inspections, drive quality culture, and supervise audit-ready batch documentation, shipment release checks, and training.

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Julphar
Julphar
22 hours ago

Manager - Sterility Assurance

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Source: Company careers pageValidated by: Fursa AI
Last checked: 22 hours agoStatus: Live

Job Summary

Lead end-to-end quality oversight for sterile pharmaceutical manufacturing, including batch certification and release as the Qualified Person (QP). Ensure cGMP and QMS compliance across sites by monitoring documentation, environmental conditions, calibrated/qualified equipment, deviations/investigations, CAPA, and change control. Own product lifecycle quality activities (PPQ, CPV, stability, APQR/PQR trends), conduct inspections, drive quality culture, and supervise audit-ready batch documentation, shipment release checks, and training.
Location: United Arab Emirates
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Manager level

Key Responsibilities

  • •Provide end-to-end Quality Assurance oversight for sterile manufacturing, including batch certification and release as Qualified Person (QP).
  • •Ensure cGMP compliance through documentation practices, batch documents/logbooks/labels, gowning/cleanliness, environmental monitoring, and calibrated/qualified equipment usage.
  • •Review and approve deviations investigations, product quality investigations (complaints/recalls), and ensure timely completion of CAPA and assessments.
  • •Own product lifecycle quality management activities including technology transfer, process validation (PPQ), continued process verification (CPV), commercial manufacturing, and product discontinuation.
  • •Conduct regular site inspections, coordinate quality improvement plan and quality culture across cross-functional teams, and ensure audit-ready batch release documentation and usage decision (UD).

Key Requirements

  • •Bachelor of Pharmacy with minimum 10+ years of experience overseeing Quality Assurance for sterile manufacturing operations.
  • •Batch release experience.
  • •Product life cycle management experience.
  • •Good experience with the QMS system.
  • •Good knowledge of cGxP and risk assessment knowledge.
Experience:10+ yearsSterile manufacturingPharmaceuticalsQMS
Education:Bachelor's
Skills:OwnershipAccountabilityCoachingTrainingQuality focus
Tech Stack:QMSCGMPCGxPSOPCAPABatch releaseChange controlRisk assessmentDeviationsInvestigationsPPQCPVAPQRPQRStability programsQualificationValidationCleaning validationFacility qualificationEquipment qualification

Company Brief

Julphar
Gulf Pharmaceutical Industries, known as Julphar, develops and manufactures a broad range of pharmaceutical products, including generics and healthcare solutions. It serves markets across the Middle East and internationally from its UAE base.
Industry: Pharmaceuticals
Company Size: Enterprise (1,001+ employees)
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Ras Al Khaimah, United Arab Emirates
Founded: 1980
WebsiteLinkedIn