Job Overview:
This is a unique opportunity to work on an advanced fill-finish facility and the company's first stand-alone vaccine and biologics plant outside the US.
* Reviewing and approving all manufacturing batch documentation including electronic batch records, real time reports, master data using site systems.
* Reviewing and approving SOPs, cleaning verification/validation data and other documents as necessary for IPT department.
* Developing effective operational procedures, training materials and maintenance procedures for various Quality related systems; ensuring all work is subsequently carried out in line with same.
* Supporting development and implementation of improved quality reporting measures.
* Liasing with Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing process.
* Providing effective real time support on the floor for day-to-day manufacturing operations e.g. area clearances, batch record reviews, aseptic operations.
* Providing quality input into decision making process on the shopfloor ensuring that product quality is maintained.
* Providing training in all aspects of Quality Management Systems and GMP.
* Ensuring all work is carried out in line with SOPs, training, or other quality systems such as change controls where applicable.
To succeed in this role you will need to possess strong skills in review and approval processes, quality management and assurance, document control, and excellent communication and interpersonal skills.
This role offers the opportunity to work in a state-of-the-art facility and contribute to the development of a new plant.
We are committed to providing a safe and healthy work environment and promoting a culture of quality and excellence.