Contract * Discipline: Good Distribution Practice (GDP) * Location: Singapore
Singapore River, Singapore
Posting date: 17 Jan 2024
Reference: 58361
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.