Title : QA Specialist, SEA
Hours: Office hours
Salary: Up to S$5800
Location: Great World City
Duration: 7 months (maternity cover)
Quality Assurance – Scope covers Singapore, Malaysia and RDC
- Process and report product complaints and deviations onto Trackwise
- Support principal release of products received inbound at RDC and outbound to SG and MY
- Support qualification and maintenance of third party vendors in an approved audit status
- Compile and update training manuals, undertake induction training and refresher training related to QMS for local affiliate staff
- Ensure all new hires and relevant trainings for current employees are completed via PATH Learning Management System
- Perform Quality and compliance specific tasks including, but not limited to processing product complaints, review of information about secondary packaging/redressing, ensure proper labelling of products at the distributor, and product recall coordination.
- Participate in the creation/update of local SOPs to reflect local practices in accordance with Corporate Policies and SOPs
- Supporting Implementing and maintaining the QMS to ensure that required processes are established Maintenance, analysis and reporting of Quality KPIs on Smart Cockpit
- Ensure local repackaging of products is performed in accordance with specifications and required licenses
- Support local and globally driven initiatives in compliance with local regulations
Pharmacovigilance:
- Support Local Safety Officer (SG) for the following:
- Manages collection, documentation, triage, translation (if applicable), transfer-ring to Corporate PV, follow up, submission to local health authorities and archiving of all adverse events for all products (drugs, devices, cosmetics) from pre and post authorization phase according to defined time-lines and quality parameters as per Corporate SOPs, 3rd party agreements (where applicable) and national regulatory requirements
- Maintain Pharmacovigilance (PV) local SOPs and supportive documents; archives these files in accordance to PV procedures and local requirements
- Maintain 24/7 coverage for PV reporting
- Performs regular adverse event reconciliation with required parties and departments, including Corporate PV
- Conduct periodic literature screening, locally initiated digital/social media, regulatory websites for safety cases and handle these according to safety case management processes
- Periodically review PV cases for signal detection and report as results to Corporate PV department
- Ensures a process in place that guarantees all associates, local 3rd parties, external vendors and local partners are adequately trained (onboarding and yearly refresher) in general adverse event reporting and ensure that accurate/updated training materials are available for that purpose
Requirements:
- Bachelor of Science Degree in Pharmacy or Life Science
- Minimum 3-5 years of Quality Assurance experience in the medical devices/pharmaceutical/cosmetic industry, preferably with some Pharmacovigilance experience
- Business level English (written and spoken)
- Experience in cosmetics, prescription, OTC and medical devices products
Interested candidate please click "APPLY" to begin your job search journey and submit your CV directly through the official PERSOLKELLY job application platform - GO Mobile.
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EA Reg. ID: R22109658 (Teng Yong Yao)
EA License No.: 01C4394
