Job Summary/Main Purpose

• 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

Key Responsibilities

• Implement sterility assurance program on site for the sterile manufacturing facilities.
• 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 & their mediafill 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.
• The incumbent will have demonstrated strong technical knowledge in the areas of design of cleanroom facilities, material flow, personnel flow, area classification and cGMP compliance.
• This role will be responsible for providing governance of all microbial monitoring controls, providing governance of microbial testing strategies for utilities, environmental and personnel monitoring.
• The role also requires providing expertise during root cause analysis investigations including OOL investigations, bioburden, endotoxin and sterility test failures as well providing support as the SME during external regulatory inspections.
• The incumbent will be the Quality partner to the teams within Sterility Assurance and work closely with members of the QA oversight and operations team. S/he will also partner to the corresponding Value Stream QA Team.
• Ensure that all in-process testing (bioburden, endotoxin) and final product testing (sterility testing) complies with pharmacopeial expectations.
• Responsible for inputs in Quality decisions for capital projects in area of consultation with other stake holders and QA Operations leaders.
• Review and evaluate the use of rapid microbiology methods and new technology to improve the microbial monitoring controls.
• Contribute to audit readiness team and internal audit, external regulatory audits and compliance responses.
• Assessment and control of critical consumables used in aseptic areas.

Core Competency

• Proactive and timely engagement of internal or external stakeholders, as necessary
• Engage the necessary stakeholders to formulate and drive projects relating to quality improvement initiatives.
• Apply good communication and project management skills
• In terms of Competency you are highly result oriented with strong sense of accountability & ownership,
• Technical Competencies: In-depth knowledge of the industry\'s standards and regulations guidelines excellent knowledge of reporting procedures and record keeping, must have experience in handling Regulatory Authorities audits and questions and accordingly set up the action plan
• Experience
• Expert in handling OOS results in Microbiological analysis, Water and Environmental monitoring.
• Strong personnel handling skills and effective team communication and motivational skills.
• Capable of suggesting ideas in a structured manner and having good Command on English language.
• You are a team player with a proactive and collaborative approach and enthusiastically manage stakeholders in good spirit.

Qualifications, Key Experiences / Functional Knowledge Requirements:

• Master Degree in Microbiology/Life Sciences
• +15 years of experience as professional in the pharmaceutical industry or equivalent combination of education and experience.
• Extensive professional experience in leading (project) teams
• Demonstrated experience in regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines.
• Experience in the manufacturing of sterile products
• Experience of microbial monitoring of aseptic manufacturing areas.
• Direct experience executing Quality Assurance function and system within a manufacturing and QC Microbiology/Sterility Assurance context.
• Experience in interacting with regulatory authorities including submissions and inspections.
• Experience in working in a global environment
• QC Microbiology experience desirable

Julphar