Permanent * Discipline: Good Manufacturing Practice (GMP) * Location: Singapore
Singapore River, Singapore
Posting date: 21 Sep 2023
Reference: 56706
Proclinical are recruiting for a Singapore QA and RA Executive to join a medical technology and devices organisation. This role is on a permanent basis and is located in Singapore.
Responsibilities:
Handle the certificate of analysis issuance and quality management with contract manufacturers.
Provide support for the new product registrations, renewals, and change notifications across Asia.
Guarantee adherence to in-house quality standards and regulatory specifications.
You will cooperate with health authorities and foreign agencies regarding regulatory concerns, licenses and permits.
Responsible for preparing and preserving documentation for audits both internally and externally.
Keep up to date on current and developing regulations, standards and guidance documentation.
Evaluate product labelling, promotional resources and advertisements for regulatory compliance.
Other duties may be assigned.
Key Skills and Requirements:
Exhibited experience in QA or regulatory affairs within a medical organisation such as cosmetic, medical device, OTC drug, etc.
Experience with GDPMDS, ISO13485, and GMP standards.
Communication skills both verbally and in writing.
An organised individual with a high attention to detail and the ability to manage own time efficiently.
Computer literacy.
Interpersonal capabilities with a positive mindset.
A self-motivated individual who works well both in a team as well as independently.
If you are having difficulty in applying or if you have any questions, please contact Mandy Fang at +65 3159 1467.
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.