Senior QA & Regulatory Affairs Leader - Pharma

SmartHire by SEEK; Petaling Jaya; On-site; MYR 75,000 - 95,000; Full time

Job summary

A pharmaceutical company in Petaling Jaya, Malaysia, is seeking a Senior QA cum RA Executive. The role ensures the highest standards of quality and compliance, managing documentation, conducting audits, and overseeing regulatory submissions. Ideal candidates will have a Bachelor's degree in relevant fields and 5-7 years of experience in QA and RA roles. If you are looking for a competitive salary and career growth opportunities, this position is for you.

Benefits

Competitive salary

Career growth opportunities

Benefits package

Qualifications

• Minimum 5-7 years in Quality Assurance and Regulatory Affairs within the pharmaceutical industry.
• Familiarity with ISO 13485, GMP, CE certifications and MDA regulations is an advantage.
• Proficiency in English is essential for effective communication and documentation.

Responsibilities

• Implement and maintain quality assurance procedures to ensure compliance with regulations.
• Perform regular inspections of manufacturing processes for adherence to GMP.
• Prepare and submit regulatory documentation for product approvals.
• Serve as the primary contact with regulatory authorities.

Skills

Quality management systems

Regulatory submission processes

Interpersonal skills

Project management

Technical proficiency in medical device manufacturing

Education

Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or related field

Master's degree

Tools

ISO 13485

Good Manufacturing Practices (GMP)

Job description

A pharmaceutical company in Petaling Jaya, Malaysia, is seeking a Senior QA cum RA Executive. The role ensures the highest standards of quality and compliance, managing documentation, conducting audits, and overseeing regulatory submissions. Ideal candidates will have a Bachelor's degree in relevant fields and 5-7 years of experience in QA and RA roles. If you are looking for a competitive salary and career growth opportunities, this position is for you.