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.