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).
