Senior Compliance and Quality Officer

2 days ago

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

At Majeton, our mission is to deliver high-quality products that meet regulatory standards. We are seeking an experienced Quality & Regulatory Affairs Specialist to join our team.

The successful candidate will be responsible for ensuring regulatory compliance, upholding product quality, and overseeing vigilance reporting for all marketed products. They will handle annual local GDPMDS and GDP inspection readiness, manage document controls, maintain SOP records, perform supplier management activities, and provide training on regulatory and quality compliance.

Additionally, they will process adverse event intake, perform signal detection, manage PV SOP compliance, and provide regulatory support in RA activities. The ideal candidate will hold a Bachelor's degree in Life Sciences, Pharmacy, or a related discipline, have at least 2 years of experience in pharmaceutical or medical device QA or RA, and be familiar with Singapore HSA regulations.

The successful candidate will be adaptable, have strong documentation and communication skills, and demonstrate eagerness to grow within the company. Benefits include competitive salary, performance-based bonuses, opportunities for professional growth and development, coffee treats from our generous colleagues, and a hard-working team who work hard and play hard.

Key responsibilities:

  • Ensure regulatory compliance and uphold product quality.
  • Manage and process adverse event intake.
  • Perform signal detection and manage PV SOP compliance.
  • Provide regulatory support in RA activities.
  • Develop and maintain SOP records.

Requirements:

  • 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.
  • Familiarity with Singapore HSA regulations.
  • Strong documentation and communication skills.
  • Adaptable and eager to grow within the company.

We offer:

  • Competitive salary and performance-based bonuses.
  • Opportunities for professional growth and development.
  • Coffee treats from our generous colleagues.
  • A hard-working team who work hard and play hard.

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