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Pharmaceutical : Quality Compliance Engineer [Job ID : 13164]

Pharmaceutical : Quality Compliance Engineer [Job ID : 13164]

PERSOLSelangorMalaysia, Selangor, Malaysia
1 hari lalu
Penerangan pekerjaan

Pharmaceutical : Quality Compliance Engineer (Job ID : 13164)

Job Title : Quality Compliance Engineer

Location : Ara Damansara, Petaling Jaya, Selangor

Employment Type : 12-month contract via PERSOL (renewable based on performance)

Working Hours : Monday – Friday, 8 : 00 AM – 5 : 00 PM

Salary : RM4,500 – RM6,000 + statutory contributions, leave entitlement, medical coverage

About the Role

Our client is seeking a Quality Engineer to ensure compliance, uphold high operational standards, and drive continuous improvement within the Quality Management System (QMS) . This role plays a key part in aligning with corporate standards and healthcare regulatory requirements, while providing support in audits, CAPA management, and cross-functional collaboration .

Key Responsibilities

  • Implement, monitor, and improve the local QMS.
  • Prepare, review, and update Standard Operating Procedures (SOPs) , ensuring compliance with corporate and regulatory requirements.
  • Support the deployment of corporate policies into the local QMS.
  • Provide regulatory / compliance guidance on operations, including customer complaints and supplier management .
  • Participate in internal, external, supplier, and regulatory audits .
  • Manage CAPA and Field Corrective Action (FCA) activities, ensuring timely closure and effectiveness.
  • Conduct QMS compliance training for cross-functional teams.
  • Support and contribute to quality improvement projects and initiatives .
  • Act as the local point of contact for all quality compliance matters.

Key Requirements

  • Bachelor’s degree in Science, Biology, Chemistry, or related field .
  • Minimum 3–5 years’ experience in a Quality function.
  • Strong analytical and problem-solving skills to interpret operational data.
  • Solid knowledge of ISO 9001 : 2015, ISO 13485 : 2016, and / or GDP / GDPMD standards .
  • ISO 13485 or GDPMD auditor certification preferred.
  • Experience in project management is an added advantage.
  • Interested candidates are encouraged to send their updated resume to : (emailprotected)
  • "Note : This job description is subject to change and includes the responsibilities and requirements described above."

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