Quality Assurance Associate (Pharma MNC, 1 year, West) #HAC

As an Associate II, Quality Assurance Compliance, you will support the implementation and maintenance of the Quality Management System (QMS), ensuring alignment with standards and policies, as well as applicable customer and regulatory requirements. You will be responsible for ensuring inspection readiness, data integrity, training compliance, and the effective operation of end-to-end quality systems, in line with global standards, regulatory expectations, and internal policies.

Key Responsibilities:

- Compile and analyze quality metrics, and support Management Review reporting

- Coordinate and prepare Annual Product Quality Review (APQR) reports

- Support document control, QMS maintenance and artwork review processes

- Support inspection readiness activities, including preparation for internal audits and regulatory inspections (e.g., Health Authorities, Notified Bodies)

- Coordinate and track responses to inspection observations, ensuring timely closure

- Review and approve change controls, ensuring compliance with regulatory expectations

- Support Data Integrity initiatives and promote compliance

- Ensure adherence to GMP, ISO 13485, MDSAP, EU MDR, and local regulatory requirements (e.g., HSA)

- Identify opportunities for continuous improvement in quality systems

Skills & Competencies:

- Knowledge of GMP and ISO 13485 quality systems, Regulatory frameworks (e.g., HSA, EU MDR, MDSAP) and Data integrity principles

- Strong ability for understanding end-to-end quality system processes and workflows and translating business requirements into effective QMS solutions, including support for system implementations and process improvements.

- Strong attention to detail and a compliance-focused mindset

- Effective communication and stakeholder management skills

- Proactive, organized, and action-oriented approach

Qualifications:

- Degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or related field

- Minimum 2 years of experience in Quality Assurance or Compliance in the pharmaceutical and/or medical device industry

All qualified candidates please send your resume to [email protected]

Anna Chen jiaxin

CEI No: R25157621

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