POSITION SUMMARY:
Reporting to the Regional Quality Assurance Manager, this role will assume primary responsibility in overseeing the quality aspect of re-dressing activity, warehousing, distribution/transportation activities and ensuring the products channeled through the supply chain system are in compliance with quality and regulatory requirement. In addition, this role will support the maintenance and improvement of Quality Management Systems of the company in compliance with Good Distribution Practices (GDP), Good Distribution Practices for Medical Devices (GDPMDS), ISO 13485, relevant local regulations of the AMAP countries, also the relevant importer and wholesaler regulations.
KEY RESPONSIBILITIES:
Quality Management System
- Support the Quality Assurance team in the maintenance and improvement of Quality Management system (QMS) for external audits and regulatory inspections
- Develop quality compliance procedures, guidelines and templates as and when necessary
- Review or modify the procedures to comply with the changes to standards, regulations, working practices where necessary
- Verify that all quality procedures are documented, implemented and deployed.
- Promotion of Quality Management Systems (QMS) awareness within the organization
- Support training of regional and local affiliates staff in QMS and processes
- Coordinate and participate in internal audits, external audits, management review to ensure that the requirements for compliance are met
- Stay up to date and build expertise in product regulations and industry best practices (e.g. Good Distribution Practices (GDP) and Good Distribution Practices for Medical Devices (GDPMDS), ISO 13485, importer and wholesaler regulations)
- Support the post audit process to ensure correction action activities are provided by accountable staffs through effective implementation
- Review and ensure closure of non-conformance (NC) and CAPA
- Monitor the compliance activities of relevant departments
- Maintenance of relevant databases and quality records
Change Control Management
- Maintain the Change Control Tracker, review forms and follow up on impact assessments and action items with stakeholders to ensure timely closure.
- Facilitate the Change Control Review Board by screening request forms, preparing meeting materials, and capturing minutes.
Document Management & Training Management
- Maintain and track Global Document adopted by AMAP, cascade the updates to the Regional and Local QA.
- Perform gap assessment of update Global processes and close Quality Event assigned by Global. Communicate child action to QA process owner.
- Assume Regional QA backup Admin for Document Management System (Documentum/Veeva Vault)
- Work with QA process owners to create training slide decks and video content for training.
- Assume Regional QA backup Admin for Training Management System (m-Learning).
Pre-market and Post-market Surveillance
- Conducts, implement and manage mock product recalls with relevant departments
- Support and coordinate mock recall across 12 AMAP countries and RDC, reviewing documentation and updating performance dashboards.
- Coordinates and manage product recall activities with relevant departments.
- Manage pre-market product non-conformities received from 3PL and manage subsequent investigation and CAPA.Manage product quality complaints on TrackWise for distribution-related issues and follow up CAPA.
CellSearch QA processes and Audit support
- Responsible for Installation & Servicing processes for IVD products.
- Maintain related SOP, monitor calibration schedules, customer feedback and complaints and coordinate measuring equipment calibration activities.
- Support all internal and external audit at regional office.
- Assume MyPortal Regional QA workspace editor role.
Incoming Release and Management of Shipments
- Perform incoming release checklist preparation to ensure products are in compliance before 3PL release.
- Review transportation temperature data logger reports, coordinate with 3PL/manufacturer for additional data and make shipment disposition decisions.
- Assist in product quality investigations as and when necessary.
- Liaise closely among inter-department (supply chain and quality assurance) to ensure product where there is compliance issue to be resolved
- Maintenance of quality records.
Projects
- Support Veeva Project
- Support Medical Device File preparation for new products
KEY REQUIREMENTS:
- At least 2 years of technical experience in pharmaceuticals / medical devices industry with oversight of QMS systems. Experience or exposure to both manufacturing and commercial environments and setup is an advantage.
- Capable of handling regulatory and quality compliance programs independently. Familiarity with various quality e-systems including Documentum, SAP, TrackWise, etc is a bonus.
- Up-to-date with industry-standard quality practices and international standards, e.g. GDP, GDPMDS, ISO 13485, etc.
- Experience or exposure to GMP/GDPMD//ISO 13485 manufacturing environment or standards preferred
- Ability to work as an active team member in a cross-function team
- Proactively build team spirit at regional / country level to ensure GMP alignment in packaging / artwork control management
- Able to develop beneficial relations with all contract service providers and regional service providers
- Task driven, self-motivated and able to work under tight schedule
- Able to engage stakeholders at different levels and drive alignment
- Able to navigate through the entrepreneur business model where processes may not always be well defined
- Strong communications skills, oral and written
- Minimal travel within APAC for audits and training
- Able to commit full time for the 1 year contract period
ABOUT MENARINI ASIA-PACIFIC
We are a global, family-owned healthcare company where our people are our priority. Present across 13 markets in Asia-Pacific, here's why you should join us:
- Local Market Expertise, Global Footprint: As a global family-owned company, we value local knowledge and expertise to invigorate the lives of patients, people and partners
- Inclusive Flexible Workplace: We are committed to foster a culture of respect and inclusive teamwork to ensure equal opportunities in a flexible workplace
- Versatile Learning and Vibrant Opportunities: Our diverse portfolio of products in varied therapeutic areas across prescription and consumer health presents opportunities for you to take ownership of your career
- Empowered to be Entrepreneurial: We operate in a dynamic, low-bureaucracy environment where swift decision-making allows us to make a real impact
- Sustainability and Care: Be part of a company that cares. Together, commit to sustainable workplaces
Join us and invigorate lives! For more information about Menarini Asia-Pacific, please visit www.menariniapac.com
