Job Description

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