Job Description

Proclinical are recruiting for a QPPV and QA Manager (3-month contract) to join a pharmaceutical organisation. This role is on a contract basis.

Responsibilities:

• Monitor all safety actions linked to products licensed within the region for which the company is registered as the MAH.
• Possess the authority to influence the set-up and performance of quality system and PV actions.
• Assist/advise within the context of PV inspections.
• Uphold awareness of present and developing PV-linked legislation/regulation within the region and discuss within the business as suitable.
• Routine meetings with global QPPV and int. dQPPV as part of the QPO Team.
• Accountable for execution of safety data exchange agreements and the updates in a timely manner.
• Evaluate audit reports of partners within the region and follow through the findings to guarantee resolution.
• Assure that Singapore, China and Korea officers are ready for GxP, such as GDP, or GVP inspections/ audits.
• You will offer adequate training of GxP regulatory needs in the Singapore, China and Korea offices.
• Other duties may be assigned.

Key Skills and Requirements:

• Educated to a degree level in a biological (life) science, pharmacology, biochemistry, physiology or closely linked field such as chemistry, pharmacy or similar.
• Demonstrable experience within Singapore GxP standards and/or experience in a Quality Assurance and Pharmacovigilance functions in pharmaceutical, medical device, biotechnology organisations.
• Works well in a team as well as independently.
• Capable of evaluating technical reports.
• Computer literacy.

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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