Key Responsibilities• Act as Quality point of contact and decision maker during New Product Introductions,Technology Transfer and Process Validation activities for Aseptic products, ensuring that allactivities meet the clients and regulatory expectations.• Quality review and approval of Process Development and Validation documentationo Technical transfer documentso Validation Protocols, executed validation documents and reports• Provide Quality direction and input at Change Control and Deviation Review Boards andassume QA oversight of change control and Deviation/CAPA records; ensuring scope ofrecord is clear and implementation activities are robust and timely.• Perform all activities in compliance with the clients safety standards and SOPsIn line with business requirements, these responsibilities may expand or otherwise includeadditional areas of responsibility which are not described in this specification but areassociated with the rolePreferred Qualifications• University degree. Science or Engineering related discipline preferred.• Understanding of principles of Validation and New Product Introduction• Experience in aseptic manufacturing• Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as aSubject Matter Expert providing overall quality direction and oversight for key functionalareas (i.e. Process Development, Validation, Manufacturing)• Experience in change control, non-conformance, corrective and preventative actions, andvalidation practices.• Ability to operate across functional boundaries, both internal and external.• Ability to work independently and remotely with minimum direct supervision.• Critical thinking skills.• Strong organisational, communication, coordination, and meeting facilitation skills.• Independent, self-motivated, organized, able to multi-task in project environments andskilled in communication and collaboration.• Team player prepared to work in and embrace a team-based culture that relies oncollaboration for effective decision-making.