QA Compliance Manager

2 weeks ago

Singapore beBeeRegulatory Full time $90,000 - $120,000
Quality and Regulatory Affairs Specialist

We are seeking a meticulous and experienced professional to join our team as a Quality and Regulatory Affairs Specialist.

Job Description

The selected candidate will be responsible for ensuring regulatory compliance, upholding product quality, and overseeing vigilance reporting for all marketed products. This includes handling and managing local annual GDPMDS and GDP inspection, maintaining and managing all controls of documents and records, managing and maintaining local GDPMDS and GDP SOP and system records, including but not limited to all product complaints, returns, disposal, internal inspection/ audit, deviation, CAPA management, etc.

Additionally, the candidate will manage new and existing supplier management activities, perform personnel training to ensure regulatory and quality compliance, manage and process AE intake for all products, perform signal detection, manage compliance of all PV SOPs, and provide regulatory support in RA activities.

Required Skills and Qualifications

To be successful in this role, you must have:

  • A Bachelor's degree in Life Sciences, Pharmacy, or a related discipline
  • At least 2 years of experience in pharmaceutical or medical device QA or RA, with some exposure to PV
  • Familiarity with Singapore HSA regulations, including Health Supplements Guidelines, Medical Device Regulations, and GDP
  • Experience in SOP writing, inspection preparation, and Quality Management Systems (QMS)
  • Strong documentation, regulatory filing, and communication skills
  • Eagerness to grow with the company and open to cross-functional learning and development
  • Adaptability and willingness to support the team with ad hoc tasks when required
Benefits

We offer competitive salary and performance-based bonuses, opportunities for professional growth and development, coffee treats from our generous bosses, and a team of hard-working colleagues who work hard and play hard.

What We Offer

This is an exciting opportunity to join our team and take on more responsibilities within the Quality & Regulatory Affairs domain. We provide training and mentorship to help you grow and succeed in your career.

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