職位描述
Main Tasks:
？ Assure execution, maintenance and improvement of the Quality Management System at all plants within the Asia GO together with the Plant QA Manager.
？ Assure compliance with the Quality Management System at all plants in Asia together with the Plant QA Manager.
？ Assure GMP/regulatory compliance at all plants in Asia together with the Plant Manager and Plant QA Manager.
o Assure together with Local Quality Management by means of regular Quality audits that the Plant Quality Systems comply with FK Corporate procedures and all relevant regulatory and certification requirements.
？ Oversight of LIMS project implementation in GO Asia
o Provision of management support and guidance to LIMS SME
？ Support the Plant QA Manager in quality investigation projects arising at the plants.
？ Escalate Quality issues to the GO QA Head
？ Quality metrics data review on a monthly basis
o Review of the monthly Quality Key Performance Indicators reported by plant.
o Regular review of the KabiTrack data to ensure the events/actions are closed in a timely manner.
o Review of the effectiveness check data generated against CAPAs.
？ Where possible, harmonise the common Operating Procedures related to the quality system at all the plants in Asia GO.
？ Assure that the Global and Divisional SOPs, WIs and GDs are implemented in the Region.
？ Where possible, harmonise and centralise the procedure and qualification activities for vendors shared by plants in Asia. Support the vendor audit programme.
？ Support the plants in the inspection readiness programme prior to regulatory inspections. In addition, provide support in the preparation and review of responses.
？ Support the plants during and after Fresenius-Kabi internal audits
？ Enhance quality educational level at all plants within the Asia region.
？ Liaise with Quality organizations of other GOs, I&D Centres and Divisions with the purpose of benchmarking against each other and share lessons learned.
？ Ensure that the procedures/Manufacturing processes filed with regulatory agencies are followed on a routine basis
？ Assist in the audits of third party manufacturing sites and implementation of technical agreements
？ Propose and support quality related investment projects
？ Ensure data integrity procedures and implemented at the plants in Asia GO
Requirements:
？ An independent working personality with high skills and experience (+ 7 years) in pharmaceutical manufacturing and experience in an international operating pharmaceutical company is preferred. University degree in pharmaceutical/biological or chemical science is a requirement and experience in aseptic manufacturing and understanding of microbiological topics is a prerequisite.
？ Open and positive character with excellent communication skills that is able to motivate people.
？ Due to the regional nature of the position the role will involve travel nationally and internationally.
？ Compliance with the FK Code of Conduct
？ Proven leadership, high integrity and communication skills
？ Fluent in English
