OVERALL RESPONSIBILITY
• Review QMS related Standard Operating Procedure (SOPs), Protocols, forms to align with QMS.
• Review ‘Quality Agreement’ with Client and negotiate the terms and conditions between client and company.
• Responsible to develop, implement and maintain the ISO standardizations that the company has to be certified ISO 9001:2015 as well as any other quality certifications required by the principals.
• Responsible to handle client audits and propose CAPA plan and follow and close out all findings within the timeline.
• Responsible to handle complaints related to the product quality and process deviation that has to be closed out successfully.
• Ensure cold-chain handling SOPs are in place and inform to client in case of temperature and cold-room deviation and communicate with principal until final treatment of the product is instructed by the principal.
• Participate as internal auditor in QMS internal audit program and conduct internal auditing process to related departments to improve the quality management system and report audit findings to the Management.
• Responsible for safekeeping and editing of company quality related documentations.
• Prepare and provide accurate management reporting periodically in timely manner.
• Train and supervise the QA Department staffs to be acknowledged to specified SOPs and processes and also train staffs from other related departments in order to comply with specified SOPs and requirements.
• Perform any necessary changes of improvement to the organization to meet the ISO requirement.
• Ensure department related documents are archived in accordance with the corporate document retention policy.
• Perform any other duties as assigned by the Management.

SKILLS OR COMPETENCIES REQUIREMENT
• Excellent communication skills.
• Excellent Quality critical thinking.
• Ability to synthesize data and summarize outcomes to provide recommendations on complaint path forward.
• Ability to independently solve problems, leads projects, and influence teams.
• Comprehensive knowledge of GSDP and QM Standards.
• Solid knowledge of industry practices.
• Excellent organizational and computing skills.
• Ability to influence and negotiate effective solutions.
• Strong critical thinking and decision making skills.

EXPERIENCE & EDUCATIONAL REQUIREMENTS
• Bachelor’s degree in Chemistry/Pharmacy.
• Minimum of 8 years’ experience in pharmaceutical with a minimum of 5 years’ experience in Quality Operations and/or external manufacturing management.
• Experience implementing Quality Management Systems in a regulated environment.
• Experience in interaction with international auditors.
• Experience in identifying compliance gaps, writing, evaluating and closing investigations with strong technical writing experience.
• Strong team player with demonstrated track record of success in a cross-functional team and fast-moving environment.