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