Team Leader - FP&A

Julphar

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 & 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.

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 as 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.