Regional Quality Assurance Associate Manager job in Singapore

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Good Pharmacovigilance Practice (GVP)

Location: Singapore

This vacancy has now expired. Please see similar roles below...

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.

Job Responsibilities

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.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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