Quality and Regulatory Manager
Salary Attractive Salary
Consultant Sean Chen Chen Xin
Date posted 29 January 2019 2019-01-292019-03-30 pharmaceuticals Jakarta ID IDR 35000000 40000000 40000000 MONTH Robert Walters https://www.robertwalters.co.id
A rapidly expanding global medical devices firm is looking for a talented Quality and Regulatory Manager in Jakarta to take on a newly created job.
About Quality and Regulatory Manager role:
Due to excellent results and future expansion plans, the Quality and Regulatory Manager will play a key role in the firm's operations and continued development and success.
- Assist and participate in local/regional internal audits as well as observing and assisting in the preparation for L2 audits
- Ensure the CAPA is closed on time; provide assistance as and when is expected from stakeholders
- Maintain APAC/ASEAN/Local Quality Management System (policies, procedures, work instructions)
- Coordination with Business Unit Q&R on the deliverables and perform gap analysis, preparation/review of document packages (CSDT) or the pre-market regulatory submissions locally and if required, regionally
To succeed in this Quality and Regulatory Manager role, you must have the ability to lead effectively and possess a keen understanding of quality and regulatory affairs for the healthcare space.
- Minimum Bachelor’s Degree in Engineering, ideally with at least 8 - 10 years' experience in quality and/or regulatory affairs
- Proficiency in the use of Microsoft Access and Excel is an advantage
- Strong interpersonal skills in the areas of verbal and written communication, telephone courtesy and professionalism
- Strong organisational skills and take initiative
- Problem solver, attention to detail and the ability to maintain confidentiality of product registration documents
The successful Quality and Regulatory Manager will join a company whose expertise has made them the leader in their field.
If you are a progressive individual with a can-do attitude, this is an excellent opportunity to work with an industry leader that is constantly breaking new ground.
Apply today or call me to discuss this new opportunity.