Regional Quality Assurance Intern

4 weeks ago

Singapore A.Menarini Asia-Pacific Holdings Pte Ltd Full time

POSITION SUMMARY:

The Regional Quality Assurance Intern will provide support to the Regional Quality Assurance (RQA) Team in the maintenance and improvement of Quality Management Systems of the regional office to support the APAC commercial business activities.

KEY RESPONSIBILITIES:

1. Quality Management System

  • Assist in the maintenance and update of the tracker for internal and external audit findings, CAPA and Change Controls
  • Records & Data Control and Maintenance – Cleansing of records and documents
  • Assist to develop regulatory compliance procedures, guidelines and templates as and when necessary
  • Assist to review or modify the procedures to comply with the changes to standards, regulations, working practices where necessary
  • Assist to coordinate and participate in internal audits, external audits, management review to ensure that the requirements for compliance are met
  • Assist to review and ensure closure of non-conformance (NC) and CAPA

2. Assist RQA in Product Quality Complaints Management

  • Support the QMS in the handling of quality complaints
  • Liaising with the local quality-responsible persons and the manufacturers on the product complaints
  • Assist in the investigation of the product complaints
  • Follow up and ensure that product complaints are closed
  • Maintenance of the product complaint database
  • Conducts periodic Product Complaint Trend Analysis
  • Conduct periodic reconciliation with Pharmacovigilance (PV)

3. Assist RQA on Incoming Release activities:

  • Perform incoming release checks (batch release) to ensure products are in compliance.
  • 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.

4. Assist RQA Training Coordinator to:

  • Ensure that every 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

5. Assist in any other assigned projects.

  • Electronic QMS (TrackWise) implementation across APAC Regional and Local QA
  • Documentum implementation across APAC Regional and Local QA
  • MILab – Product study and Process development

KEY REQUIREMENTS:

1. Experience and qualification

  • Diploma or degree in science or related discipline
  • Familiar with MS Office and Google Workspace applications

2. Competencies and soft skills

  • Growth Mindset
  • Passionate/enthusiastic to make improvements and drive change
  • Able to work proactively and independently
  • Task driven, self-motivated and able to work under tight schedule
  • Willing to engage stakeholders at different levels to drive alignment
  • Comfortable to operate in ambiguous environment where processes are not well defined
  • Good communications skills, both oral and written.

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