QPPV and QA Manager
Proclinical are recruiting for a QPPV and QA Manager to join a pharmaceutical organisation. This role is on a permanent basis.
- 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 firstname.lastname@example.org.
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.