Quality Assurance Executive

Goodscience; Kedah; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading Pharmaceutical company in Kedah, Malaysia is seeking a qualified individual with a Degree in Science or Pharmaceutical Technology and experience in the Pharmaceutical or Medical Device industry. Responsibilities include ensuring compliance with Quality Systems, assisting in regulatory audits, and managing pharmacovigilance activities. This role offers an opportunity to contribute to critical industry standards and practices.

Qualifications

• Minimum of 2 years working experience in relevant industry.
• Fresh graduates in Pharmaceutical Technology or related field are welcome.

Responsibilities

• Implement Quality Systems in compliance with approved procedures.
• Review documents related to change control and product quality.
• Assist in regulatory audits and quality risk assessments.
• Train new recruits on Good Manufacturing Practices.
• Support pharmacovigilance activities and manage compliance.

Skills

Degree in Science or Pharmaceutical Technology

Experience in Pharmaceutical or Medical Device Industry

Fresh graduates encouraged

Education

Degree in Science or Pharmaceutical Technology

Job description

Qualifications

• Degree in Science or Pharmaceutical Technology with at least 2 years working experience in Pharmaceutical or Medical Device Industry.
• Fresh graduates in Pharmaceutical Technology/ related field are encouraged to apply.

Responsibilities

• Compliance
  • Ensuring the implementation of the Quality Systems in the company to be in accordance with approved procedures.
  • Review evidences and supporting documents related to change control, deviation, CAPA, product quality review and others submitted by the head of departments.
  • Review product complaint investigation reports by relevant departments and establish final report for submission to QA HOD.
  • Assist in readiness for regulatory audit (NPRA/Medical Device audits)
  • Participate in quality risk assessment activities.
  • Conduct induction training (Good Manufacturing Practices, Good Documentation Practices) for new recruitment's.
  • Assist in supplier/vendor audit and assessment program for material supplier, service providers and third-party quality control laboratory.
• Pharmacovigilance (PV)
  • Act as liaison between PV Team for all activities pertaining to pharmacovigilance.
  • Assist and provide support in the management of all pharmacovigilance activities
  • Conducted by the organization in compliance with regulatory requirements and timelines.