QA EXECUTIVE

3 weeks ago

Singapur, Singapore FEI FAH MEDICAL MANUFACTURING PTE LTD Full time

QA Executive

He/ She supports the Quality Head in the implementation and maintenance of quality systems to ensure the company's products meet quality standards and comply with regulatory requirements. This role involves documentation, execution of quality-related activities, internal audits, and coordination across departments to ensure consistent quality practices throughout the organization.

Responsibilities:

  • Assist in maintaining and improving the QMS by applicable regulatory and GMP requirements.

  • Conduct routine quality control checks on raw materials, packaging materials, in-process, and finished goods according to approved specifications and procedures.

  • Support manufacturing activities, including sampling, inspection, documentation, and coordination with production.

  • Participate in environmental monitoring of cleanroom and production areas, and ensure timely reporting of results.

  • Support documentation review processes (e.g., batch records, SOPs, deviation reports, change control, CAPA records).

  • Assist in the release process of finished products by verifying documentation and test results.

  • Support internal and external audits/ inspections, including documentation collation and follow-up of action plans.

  • Conduct investigations for deviations, OOS results, and customer complaints, and assist in implementing and monitoring CAPA.

  • Maintain training records and assist in conducting training sessions on quality and GMP topics. Coordinate with suppliers and service providers for documentation, material evaluations, and audits as required.

  • Track quality trends and support the Quality Head in implementing necessary changes.

  • Ensure all records, logs, and reports are complete, accurate, and filed promptly.

  • Perform ad hoc duties as assigned.

Requirements:

  • Diploma or Bachelor's Degree in Science or equivalent.

  • Minimum 2 years of experience in QA/ QC in pharmaceutical/ medical device/ cosmetic/ health product manufacturing.

  • Good understanding of GMP, QMS, and regulatory requirements.

  • Strong attention to detail, good documentation practices, and organizational skills.

  • Ability to work independently and as part of a cross-functional team.

  • Takes initiative to study regulations and technical requirements during personal time to enhance knowledge, especially in areas with limited hands-on industry experience.

  • Good written and verbal communication skills.

  • Proficient in Microsoft Office applications.

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