Job Responsibilities

 Support the start-up of Quality Systems for the site.  Execute and maintain the Quality Systems at the site.  Document Management System  Write, Revise, Review and Approve Standard Operation Procedure, protocols, reports or records.  Conduct training  Provide guidance on Current Good Manufacture Practices, Good Documentation Practices and Data Integrity requirements.  Training/Learning Management System  Maintenance of training curriculum/tasks.  Custodian and archival of training records.  Provide guidance on Learning Management System usage.  Trackwise System  Provide guidance on deviation management, change control and Corrective And Preventive Actions  Conduct training and provide guidance on trackwise system usage.  Communicate quality systems and compliance requirements effectively to peers and stakeholders.  Provide compliance support to staff in all departments.  Participate in regulatory, customer and internal audits.  Any other tasks as and when assigned by the supervisor/line manager.

Job Requirements

 Familiarity with Regulatory requirements and local Codes & Standards (e. g. , Food and Drug Administration, European Agency for the Evaluation of Medicinal, Good Automated Manufacturing Practice and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)  Good knowledge and experience of the practical and theoretical requirement of validation program in Good Manufacture Practices facility  Good leadership skills  Strong interpersonal skills  Effective Communicator (oral and written)  Exhibit good quality decision making traits  Meticulous and Systematic  Analytical Mind  Ability to define specific goals clearly, to develop and prioritize activities  Team player, with strong focus on safety, quality and timelines

Required Languages

English