Job Description

Our client is a Singapore Biopharmaceutical company developing, manufacturing and marketing in APAC and Europe.

This position is a temporary role for 6 months contract, need to work on-site.

Responsibilities:
Quality Assurance

• A good understanding of GDP for MD and compliance in GDP setting performing both supervised and unsupervised tasks
• Responsible person of SG Importer & Wholesaler Licence
• Provide support in management review, internal audits and QA-related vendors
• Attend to external audits from HSA or HSA-notified bodies and support other QA audits in other regions.
• Creating and maintenance of QA SOPs and QA Contract
• Management of secondary packaging site and process
• Liaise with manufacturer and distributors on product complaints, temperature excursions, quarterly reconciliation
• QA training of internal and external stakeholders
• Conduct/approve validation of transport processes and systems

PV

• Support oversight and set up of PV operational and case management activities
• Attend to external audits and resolve CAPA related to findings from audits
• Perform reconciliation to the implementation of safety and safety processes. Reviews and contributes to any PV documentation;
• Review of PV content in agreements and contracts (PVAs, DAs, service agreements, etc)
• PV training of internal and external stakeholders
• Ensure PV service providers are performing PV services (literature searches, case processing, signal detection)
• Review and disseminate PV related reports

Requirements:

• Bachelor\'s Degree in Life Science or equivalent with at least 1-3 years relevant work experience with good exposure to QA & PV in the Pharmaceutical/medical device industry
• Strong written and oral communication skills. Technical report writing skills are an advantage.
• Able to work independently and collaboratively.
• Experience working in a cross-functional, matrix environment.
• Able to manage multiple priorities and meet scheduled milestones
• Proficient with Microsoft Office Suite (Outlook, Word, Excel)

Temporary (6 months contract), On-site
Responsibilities:
Quality Assurance

• A good understanding of GDP for MD and compliance in GDP setting performing both supervised and unsupervised tasks
• Responsible person of SG Importer & Wholesaler Licence
• Provide support in management review, internal audits and QA-related vendors
• Attend to external audits from HSA or HSA-notified bodies and support other QA audits in other regions.
• Creating and maintenance of QA SOPs and QA Contract
• Management of secondary packaging site and process
• Liaise with manufacturer and distributors on product complaints, temperature excursions, quarterly reconciliation
• QA training of internal and external stakeholders
• Conduct/approve validation of transport processes and systems

PV

• Support oversight and set up of PV operational and case management activities
• Attend to external audits and resolve CAPA related to findings from audits
• Perform reconciliation to the implementation of safety and safety processes. Reviews and contributes to any PV documentation;
• Review of PV content in agreements and contracts (PVAs, DAs, service agreements, etc)
• PV training of internal and external stakeholders
• Ensure PV service providers are performing PV services (literature searches, case processing, signal detection)
• Review and disseminate PV related reports

Requirements:

• Bachelor\'s Degree in Life Science or equivalent with at least 1-3 years relevant work experience with good exposure to QA & PV in the Pharmaceutical/medical device industry
• Strong written and oral communication skills. Technical report writing skills are an advantage.
• Able to work independently and collaboratively.
• Experience working in a cross-functional, matrix environment.
• Able to manage multiple priorities and meet scheduled milestones
• Proficient with Microsoft Office Suite (Outlook, Word, Excel)

Interested applicants please send your resume to:

Lisa HU

Email: lisa.hu@jac-recruitment.com

EA Licence: 90C3026

EA Personnel No: R23114940

We regret to inform that only shortlisted candidates will be notified.

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#countrysingapore

JAC Recruitment