Quality Assurance Compliance Specialist | Pharmaceutical & Medical Device Industry #HDC

Are you passionate about quality, compliance, and driving continuous improvement in a highly regulated environment? We are looking for a Quality Assurance Compliance Specialist to support and enhance Quality Management System (QMS) operations while ensuring compliance with global quality standards and regulatory requirements.

This is an excellent opportunity to be part of a dynamic manufacturing environment where you will play a key role in maintaining inspection readiness, strengthening quality systems, and supporting business excellence initiatives.

Key Responsibilities

• Support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
• Compile, analyze, and report quality metrics for management review.
• Coordinate and prepare Annual Product Quality Review (APQR) reports.
• Manage document control activities and support artwork review processes.
• Assist in audit and inspection readiness for internal and external regulatory assessments.
• Coordinate responses to audit findings and ensure timely completion of corrective actions.
• Review and support change control activities in accordance with regulatory and internal compliance requirements.
• Promote data integrity initiatives and ensure adherence to ALCOA+ principles.
• Ensure compliance with GMP, ISO 13485, MDSAP, EU MDR, HSA requirements, and other applicable quality standards.
• Identify opportunities to streamline processes and strengthen quality system effectiveness.

Requirements

• Degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or related discipline and above.
• Minimum 2 years of relevant experience in Quality Assurance or Compliance within the pharmaceutical and/or medical device industry.
• Good understanding of GMP, ISO 13485, quality management systems, regulatory frameworks, and data integrity principles.
• Strong analytical, problem-solving, and organizational skills with excellent attention to detail.
• Ability to manage multiple priorities, work collaboratively with cross-functional stakeholders, and communicate effectively.
• A proactive mindset with a passion for maintaining high quality and compliance standards.

Interested applicants, please send your updated resume to Sign in to view email.

Leon Leong De Cong

R1551708

Recruit Express Pte Ltd

EA License No. 99C4599