Job Summary
The Quality Assurance & Regulatory Affairs, Executive will report to the Regulatory Affairs & Quality Assurance, Manager and he/she will assume primary responsibility in providing quality assurance and control expertise to the Menarini team and Partners; and support the Regulatory Affairs & Quality Assurance, Manager in the regulatory affairs and quality assurance functions. He/she will also be responsible to undertake regulatory project management and ensure regulatory compliance in Singapore as required.
Job Responsibilities
- Prepare and conduct QMS audits with management review in accordance with SS 620 GDPMDS and/or HSA GDP requirements
- Prepare, review and maintain QMS required SOPs and ensure proper documentation in accordance with SS 620 GDPMDS and/or HSA GDP requirements
- Process and report product quality complaints/product defect to the authority, Regional and/or Partners. Review complaint investigations, CAPA plan and effectiveness review and monitoring of complaint trends and reporting the trends
- Manage deviations and CAPA and ensure timely investigation, closure and implementation
- Review and submit change controls to assess the impact of change and ensure timely implementation
- Liaise with distributor on the secondary repackaging requirements and prepare repackaging instructions and request forms
- Ensure product specifications, labels and related documentation are in alignment with current registered information
- Coordinate post marketing surveillance activities such as FSCA and product recalls
- Ensure compliance is in place for all product post market registration conditions
- Provide training for internal stakeholders on quality SOPs and ensure compliance with company policy
- Maintain database of registrations, change controls, deviations and product quality complaints
- Planning, preparing and submitting new marketing authorization applications for Singapore
- Planning, preparing and submitting post approval changes including variations, change notifications, renewals etc. for Singapore and work with relevant stakeholders to ensure business continuity
- Liaise with the local authorities to ensure timely regulatory approvals in meeting business plans
- Develop regulatory strategies during the preparation of new application, renewal and variation submissions to address gaps and communicate its impact
- Review and approve labels and promotional materials for regulatory compliance
- Supports any other relevant activities or as required
Requirements
- Candidate must possess at least a Bachelor's Degree in Science, Engineering or Pharmacy
- Understanding of regulatory standard related to cGMP, GDP, SS620, PIC/S, ISO 13485 and cold chain management
- Certified internal auditor for GDPMDS or ISO13485 is required
- Experience in audit, QA batch management, complaint management, deviation management, change control management, CAPA and recall management
- Minimum 2 years’ experience in commercial quality assurance in pharmaceutical or medical device industry
- Regulatory experience in therapeutic products, medical devices, cosmetics, traditional medicine and/ or health supplement is a bonus
- Ability to work both as an individual and as a team player
- Ability to influence and collaborate with people at all levels effectively
- Proficient in both oral and written English
- Computer literate
- Attention to details and results oriented
- Flexible and adaptive to changes
