Job Description

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.

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