Job Summary: Working with APAC + China Regional Established Pharmaceuticals QA organization to provide support and guidance regarding document management, training, metrics and management review ensuring compliance with regulations and Quality System requirements. This position is responsible in day-to-day activity and to support implementation and management of quality systems and training programs, as necessary. The role also includes auditing of third-party manufacturers or suppliers, as assigned
Job Scope:
Quality System Compliance
· General compliance support
o Lead and provide compliance-related and capability-building support to APAC and China sites and commercial affiliates.
o Take ownership to continuously simplify processes
· Training
o Create training materials and deliver training as requested. Maintain training matrixes for assigned staff.
o Interacts with Corporate Functions and represents APAC and China on corporate initiatives related to training.
o Training management system administration and support
· Documentation management
o Lead coordination and review of new and revised procedures.
o Lead coordination and execution of impact review post approval and post obsolescence of procedures.
o Create training materials and deliver training as requested.
o Interacts with Corporate Functions and represents APAC and China on corporate initiatives related to document management.
o Documentation management system administration and support
· eQMS management
o Create training materials and deliver training as requested.
o Interacts with Corporate Functions and represents APAC and China on corporate initiatives related to Trackwise management and use.
o Trackwise system administration and support
· Quality Audit
o Conduct regional or internal audits on internal or external sites and commercial affiliates, as assigned.
· Commercial Affiliates Support
o To provide support on quality initiatives of commercial affiliates
· Execute projects and tasks as assigned
o Lead Quality program and projects in APAC and China regions.
o Participates in program reviews and provide appropriate recommendations to ensure Quality requirements are met and within established QA processes.
o Prioritizes deliverables and manages project scope and End-to-end QA delivery across teams/sites.
o Report out status of the projects to QA Leadership team on a periodic basis using project related metrics and track projects to resources, time to market and budget constraints.
o Advise Senior Management of programs status and risks. Oversee decision-making process in determining projects and associated activities in manufacturing sites. Coordinate activities between site/project team members as necessary to ensure requirements are met in respect to project management
o Others as assigned
Requirements:
· Bachelor Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area
· 5- 10+ years in a Pharmaceutical industry (the position will commensurate with the incumbent’s experience).
· Knowledge of relevant regulations for quality systems and compliance. Good understanding of SOPs, GMPs and quality systems (e.g. ISO, Auditing).
· Manufacturing or Quality related experience.
· Capable of understanding and communicating cross-culturally to provide solutions that satisfy corporate, regional, and local objectives. Understanding of cultural practices and cultural expectations within relevant markets in the region is necessary. To have worked in a multicultural environment is highly desirable
· Proficient with Microsoft Office Suite (intermediate MS Excel knowledge required), Adobe Acrobat, Visio, MS Access. System experience preferred using Trackwise, iQ, Isotrain, and general IT system data entry and report generation desired.
· Excellent collaboration skills, communication skills, problem solving competence & organizational skills.
Additional Information:
· Contract duration: 12-month contract
· Commencement Date: Immediate
· Working days and hours: Mon to Friday, 9am to 6pm
· Location: Bugis, DUO Tower
