Senior QA RA Executive

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

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Our client ISDMeditech Sdn. Bhd. is seeking a Senior QA cum RA Executive to join their team!

This role offers a unique opportunity to ensure the highest standards of quality and compliance in a growing pharmaceutical company. You will be instrumental in maintaining product integrity and regulatory compliance, contributing to the company's success and growth.

About Our Client

Our client ISDMeditech Sdn. Bhd. is a dynamic and expanding company in the pharmaceutical industry, committed to providing high-quality medical products and services. With a strong focus on growth and innovation, they offer a supportive and progressive work environment.

What you'll be doing?

Develop QA protocols: Implement and maintain quality assurance procedures to ensure compliance with industry standards and regulations.

Conduct audits: Perform regular inspections of manufacturing processes to ensure adherence to Good Manufacturing Practices (GMP) and other relevant standards.

Manage documentation: Review and approve batch records, quality control tests, and other product quality-related documentation.

Drive continuous improvement: Collaborate with cross-functional teams to enhance product quality and process efficiency.

Lead regulatory submissions: Prepare and submit regulatory documentation to ensure timely approval of products by relevant regulatory bodies.

Ensure compliance: Stay current with global regulatory requirements and guidelines to maintain product compliance with the latest standards.

Manage certifications: Oversee ISO 13485, 9001, and other relevant compliance updates in accordance with changes and process improvements.

Liaise with authorities: Serve as the primary point of contact with regulatory authorities, responding to queries and providing necessary information.

Who are they looking for?

Educational background: Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a relevant field. A Master's degree is a plus.

Quality management expertise: Excellent understanding of quality management systems and regulatory submission processes.

Experience: Minimum 5-7 years in Quality Assurance and Regulatory Affairs within the pharmaceutical industry.

Communication skills: Excellent interpersonal and collaborative abilities to work effectively across departments.

Industry knowledge: Familiarity with ISO 13485, GMP, CE certifications, and MDA regulations is an advantage.

Technical proficiency: Knowledge of medical device manufacturing processes, quality control processes, and testing methods for medical products.

Project management: Ability to manage multiple projects and deadlines simultaneously while working under pressure.

Language: Proficiency in English is essential for effective communication and documentation.

Why should you consider this opportunity?

Competitive salary and benefits package.

Career growth and advancement opportunities.

How to apply

Ready to join this role? Click Apply now to submit your resume and share your availability and expected salary with us!

We welcome all applicants, regardless of experience or qualifications.

All information received will be kept strictly confidential and will be used only for employment-related purposes.

Unlock job insights

Your application will include the following questions:

• Which of the following statements best describes your right to work in Malaysia?
• What's your expected monthly basic salary?
• Which of the following types of qualifications do you have?
• Which of the following languages are you fluent in?
• How much notice are you required to give your current employer?

What can I earn as a Regulatory Affairs Executive