Senior QA/PV Specialist, SEA (6 month)

Location: Singapore
Job Type: Contract
Specialisation: Life Sciences
Salary: S$4000 - S$4500 per month
Reference: BBBH9530_1626153845
Contact: Abhik Damani
Email: email Abhik

My client is a global name in the life sciences industry and is going through a transformation. To cater to this, a new QA/PV Specialist role has been created.

This role will work closely with the Senior PV Manager and manage QA/PV activities in the region and support my client's distribution centres. This is a 6 month contract role

Responsibilities:

  • Implement and manage a vigilance system to contribute to post marketing surveillance and safe use of products in accordance with regulatory requirements
  • Support release of products received inbound at distribution centres and outbound to other countries in SEA
  • Compile and update training manuals and undertake induction training related to QMS
  • Perform Quality and compliance specific tasks such as processing product complaints, review information about secondary packaging and product recall coordination.
  • Create local SOPs to reflect local practices in accordance with Corporate Policies
  • Ensure local repackaging of products is performed in accordance with specifications and required license
  • Manage collection, documentation, transferring to Corporate PV, submission to local health authorities and archiving of all events for all products from pre and post authorization phase
  • Maintain Pharmacovigilance local SOPs and supportive documents
  • Perform regular adverse event reconciliation with required parties and departments
  • Review PV cases for signal detection and report as results to Corporate PV department
  • Implement and follow up of CAPA until resolution

Requirements:

  • Degree in Life Sciences or equivalent with at least 2 - 4 years' experience within RA/QA/PV
  • Experience in the biopharma/cosmetics/OTC/medical device space
  • Excellent communication and negotiation skills

Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).