Regional Quality Assurance Associate Manager
A large and established organisation are looking for an experienced Regional Quality Assurance Associate Manager in Singapore. This organisation is dedicated to saving roles and this would be the perfect opportunity to be a part of this medical journey.
- Assume the Quality Management Representative (QMR) within the organisation and main Quality Management system (QMS) contact person for internal & external audits
- Manage and coordinate internal & external audits and management reviews to ensure that the requirements for compliance are met
- Qualification of secondary repackaging facility
- Review of quality agreement with regional/local 3rd parties for warehouse, distributors, service providers, freight forwarding, etc.
- Review of deviations and follow-up on CAPA.
- Audit on GSP & GDP compliance based on WHO and/or PIC/s guideline.
- Support Validation/ Data logger interpretation.
- Conduct periodic reconciliation with Pharmacovigilance (PV)
- Assist in product quality investigations as and when necessary.
- Ensure that every team member in their department has the latest training plan based on their current job function
- Coordinate with Functional Head or delegate in training plan maintenance including module creation, modification or module cancellation
- Maintain the training materials and documented training completion
- Assume point of contact role to department employees for any training update or training requirements, including external training
- Update training log or equivalent
Skills and Requirements
- 4-5 years of quality and technical experience in pharmaceuticals / medical devices industry with oversight of QMS systems
- be capable of handling regulatory and quality compliance programs independently
- be up-to-date with industry-standard quality practices and international standards, e.g. GDP, GDPMDS, ISO 13485, etc.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.