Team Leader - Sterile Value stream (QA)

At Julphar, we are on a journey of culture transformation and our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism. Our core values: Respect, Collaboration, Innovation, Integrity and Compassion - combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents, create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.

• Provide Quality Assurance Oversight for Sterility Assurance Monitoring Control Standards and knowledge Management in Monitoring Control.
• Provide Sterility Assurance Quality team leadership and support to Value Stream in matters related to Sterility Assurance.
• Develop contamination control strategy for manufacturing facilities in Julphar.
• Provide Quality Assurance governance for the microbial Monitoring controls.

• Implement sterility assurance program on site for the sterile manufacturing facilities.
• Handling of deviations, change control, market complaints, CAPA and risk assessment related to sterile operations.
• Review and approve gap/risk assessments relating to Sterility Assurance.
• Provide QA oversight to Sterility Assurance for site manufacturing processes and products manufactured by the site including setting the product specifications and in-process controls.
• Ensure the gowning qualifications for persons working inside aseptic areas and their media fill participation.
• Provide input on aspects relating to Sterility Assurance for qualification and validation strategies including media fills and production equipment qualifications.
• Work collaboratively with the operations QA oversight team to provide a holistic microbial contamination control strategy at each sterile manufacturing plant and the necessary risk assessment, mitigation plans.
• Demonstrate strong technical knowledge in the areas of cleanroom design, material flow, personnel flow, area classification and cGMP compliance.
• Provide governance of all microbial monitoring controls and microbial testing strategies for utilities, environmental and personnel monitoring.
• Provide expertise during root cause analysis investigations including OOL investigations, bioburden, endotoxin and sterility test failures and act as SME during external regulatory inspections.
• Serve as the Quality partner to the Sterility Assurance teams and collaborate with the QA oversight and operations teams, and with the corresponding Value Stream QA Team.
• Ensure that all in-process testing (bioburden, endotoxin) and final product testing (sterility testing) complies with pharmacopeial expectations.
• Contribute to Quality decisions for capital projects in consultation with other stakeholders and QA Operations leaders.
• Review and evaluate the use of rapid microbiology methods and new technology to improve microbial monitoring controls.
• Contribute to audit readiness, internal audits, external regulatory audits and compliance responses.
• Assess and control critical consumables used in aseptic areas.

• Proactive and timely engagement of internal or external stakeholders as necessary.
• Engage stakeholders to formulate and drive projects related to quality improvement initiatives.
• Apply good communication and project management skills.
• Result oriented with strong sense of accountability and ownership.
• Technical competencies: in-depth knowledge of industry standards and regulations; excellent knowledge of reporting procedures and record keeping; experience handling Regulatory Authorities audits and corresponding action plans.
• Experience in handling OOS results in Microbiological analysis, Water and Environmental monitoring.
• Strong personnel handling, team communication and motivational skills.
• Ability to suggest ideas in a structured manner and strong command of English.
• Team player with a proactive and collaborative approach and ability to manage stakeholders in good spirit.

• Degree in Pharmacy/Life Sciences
• years of experience in the pharmaceutical industry or equivalent combination of education and experience.
• Extensive experience leading (project) teams.
• Regulatory compliance experience with GxP, FDA, EU and other regulatory guidelines.
• Experience in manufacturing of sterile products.
• Experience in microbial monitoring of aseptic manufacturing areas.
• Direct experience executing Quality Assurance functions and systems within a manufacturing and QC Microbiology / Sterility Assurance context.
• Experience interacting with regulatory authorities including submissions and inspections.
• Experience working in a global environment.
• Sterile plants working experience is desirable (vials, ampoules, PFS, lyophilization and cartridge filing).

We value people from different backgrounds. Could this be your story? Apply today or visit to read more about us and the journey of Julphar

• Mid-Senior level

• Full-time

• Quality Assurance
• Industries: Pharmaceutical Manufacturing

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