Team Leader - Sterile Value Stream QA

About the role

Julphar is looking for a Team Leader for its Sterile Value Stream QA position in Ras Al Khaimah. The role provides quality assurance oversight for sterility assurance monitoring, control standards and knowledge management, leads the Sterility Assurance Quality team and develops contamination control strategies for sterile manufacturing facilities.

Key responsibilities

• Implement the sterility assurance programme on site and govern microbial monitoring controls, testing strategies for utilities, environmental and personnel monitoring, and product specifications and in-process controls.
• Handle deviations, change control, market complaints, CAPA and risk assessments; review and approve gap and risk assessments.
• Ensure gowning qualifications for personnel in aseptic areas and their media fill participation, and contribute to qualification and validation strategies.
• Work with the operations QA oversight team to build a holistic microbial contamination control strategy and risk mitigation plans.
• Support root cause analysis of OOL, bioburden, endotoxin and sterility test failures, and act as subject matter expert during external regulatory inspections.
• Ensure in-process and final product testing meets pharmacopoeial expectations, and advise on capital projects and rapid microbiology methods.
• Contribute to audit readiness and compliance responses, and assess critical consumables used in aseptic areas.

Required profile

• Degree in Pharmacy or Life Sciences plus 10 years of experience in the pharmaceutical industry, or an equivalent combination of education and experience.
• Extensive experience leading project teams and hands-on experience in the QA function within manufacturing and QC microbiology/sterility assurance.
• Experience with regulatory compliance (GxP, FDA, EU) and with regulatory authority submissions and inspections.
• Experience in a global environment; sterile plant experience (vials, ampoules, PFS, lyophilisation, cartridges) is desirable.

Required skills

• In-depth knowledge of industry standards, regulations and guidelines, and of reporting and record keeping.
• Expertise in handling OOS results in microbiological analysis, water and environmental monitoring.
• Good command of English and strong communication, project management and stakeholder engagement skills.