An exciting new opportunity has come up and a global Medical Device MNC is seeking an experienced Associate RA/QA Manager to join their expanding team in Singapore. The successful incumbent will report to the Head of RA/QA.

Quality Assurance

• Ensure products delivered meet legal and customers' requirements
• Drive the quality improvement programs and activities and seek for continuous improvement.
• Deal with process quality issues; and deal with customers' quality issues & enquiries.
• Monitor GMP & QA activities of the company for regulatory compliance
• Outline quality assurance policies and procedures
• Interpret and comply with quality assurance standards
• Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies
• Participates in Regulatory and Customer Audits.
• Oversee the implementation and ensure efficiency of inspection and quality systems
• Document quality assurance activities, such as internal audits
• Analyze customer grievances and other non-compliance issues
• Providing training for employees to ensure compliance with SOPs
• Analyze audit outcomes and carry out appropriate corrective procedures
• Set up and maintain pharmaceutical and medical device quality system in accordance with the company's quality policy
• Maintain a good documentation system for organizing controlled documents and retaining records of manufacture which enable the complete history of a batch to be traced, readily available and easily traceable
• Ensure established Quality Management System such as Product Complaint & Recall, Internal &External Audits, Vendor Management, Deviation Management, CAPA, Change Control and Quality Risk Management are effectively implemented, monitored and in compliance with cGMP / authority requirements

Regulatory Affairs

• Lead the formulation of registration strategy for products/projects. Ensures effective implementation of the strategies and adhere to corporate objectives and business goals.
• Regulatory knowledge: Maintains a high level of regulatory knowledge on global/regional regulatory requirements and provides regulatory guidance for global counterparts.
• Agency interactions: Acts as core point of contact to relevant authorities/external organizations (CROs, NBs, etc) for products/projects. Liaises, negotiates and lead interactions, including appropriate documentation of the interaction, decisions and outcomes.
• Dossier submissions: independently leads the preparation, coordination or monitoring or regulatory submissions. Interacts across APAC and global to obtain and/or provide information/data for regulatory submissions.
• Coordinates change control responses from APAC countries and stock build if required with supply chain department.

You should have at least 7 years' of RA/QA experience and a relevant science degree.

To be considered for this opportunity, please kindly apply with your updated CV.

Ambrose Chan

Registration Number: R1218177
EA License Number: 17C8502