Sterility Assurance QA Lead - Value Stream

Julphar; Ras Al Khaimah; On-site; AED 200,000 - 700,000; Full time

Job summary

Julphar is seeking a senior professional to lead Sterility Assurance. You will oversee sterility programs, provide QA governance, and collaborate with global teams to ensure compliance and robust contamination control across sterile manufacturing facilities.

You will drive deviations handling, CAPA, risk assessment, and regulatory readiness, partnering with QA oversight and operations teams to maintain high-quality sterile products. Strong communication in English is essential.

Qualifications

• Degree in Pharmacy or Life Sciences.
• +10 years of experience in the pharmaceutical industry or equivalent.
• Experience leading (project) teams.
• Regulatory compliance with GxP, FDA, EU guidelines.
• Experience in sterile product manufacturing.
• Experience in microbial monitoring of aseptic areas.
• Direct experience in QA within manufacturing and QC Microbiology/Sterility.
• Experience interacting with regulatory authorities including submissions and inspections.
• Experience in global work environments.
• Sterile plants experience desirable (vial, Ampoules, PFS, Lyo, cartridge).

Responsibilities

• Implement sterility assurance program on site for sterile facilities.
• Handle deviations, change control, market complaints, CAPA and risk assessments related to sterile operations.
• Review and approve gap/risk assessments relating to Sterility Assurance.
• Provide QA oversight to Sterility Assurance for site processes and products, including specifications and in-process controls.
• Ensure gowning qualifications for aseptic areas and media fill participation.
• Contribute to qualification and validation strategies for sterility-related activities.
• Collaborate with operations QA to develop a holistic contamination control strategy.
• Provide SME support during external regulatory inspections and audits.
• Ensure all in-process and final sterility testing meets pharmacopeial standards.

Skills

Stakeholder management

Communication

Project management

Result oriented

Regulatory knowledge

OOS handling

Team leadership

Contamination control

IAgile collaboration

English proficiency

Education

Degree in Pharmacy/Life Sciences

Job description

Julphar is seeking a senior professional to lead Sterility Assurance. You will oversee sterility programs, provide QA governance, and collaborate with global teams to ensure compliance and robust contamination control across sterile manufacturing facilities.

You will drive deviations handling, CAPA, risk assessment, and regulatory readiness, partnering with QA oversight and operations teams to maintain high-quality sterile products. Strong communication in English is essential.