Permanent * Discipline: Good Distribution Practice (GDP) * Location: Singapore
Singapore River, Singapore
Posting date: 17 Jan 2024
Reference: 58362
Proclinical are recruiting for a QPPV and QA Manager to join a pharmaceutical organisation. This role is on a permanent basis.
Responsibilities:
Handle QMS to comply with local GxP guidelines and execution changes to QMS when there are pertinent alterations in guidelines.
Guarantee that Singapore, China, and Korea offices are ready for GxP such as GDP or GVP inspections/audits.
Accountable for execution of safety data exchange agreements and the updates in a timely manner.
Obtain overview of safety profiles and developing safety concerns for all products within the region.
You will Monitor all safety actions linked to products licensed within the region for which the business is registered as the MAH rendering to present local OV legislations.
Assist/advise in the context of PV inspections.
Uphold awareness of both present and developing legislation/regulation in the region and discuss with the business as suitable.
Routine meetings with global QPPV and int. dQPPV as part of the QPO Team.
Other duties may be assigned.
Key Skills and Requirements:
Educated to a degree level in a biological life science, pharmacology, biochemistry, physiology or similar field.
Demonstrable experience in Singapore GxP standards and/or experience in Quality Assurance and Pharmacovigilance functions in a pharmaceutical, medical device, biotechnology organisations.
Works well both individually as well as in a team.
Capable of evaluating technical reports.
Computer literacy.
Communication skills both verbally and in writing.
Fluency in the English language.
A precise, flexible individual with the ability to work well while under pressure.
Comprehension of concerns from various perspectives or point-of-view.
Analytical abilities, takes a systemic approach to successfully sole all concerns.
Able to think and act strategically.
If you are having difficulty in applying or if you have any questions, please contact Cherry Medrano at c.medrano@proclinical.com.sg.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.