Executive, QMS & Regulatory Affairs

Ori Bionature (M) Sdn Bhd; Puchong; On-site; MYR 48,000 - 60,000; Full time

Job summary

A food safety company in Puchong is looking for a Quality Management Specialist to maintain QMS documentation and ensure compliance with standards like ISO and HACCP. Responsibilities include supporting integration of quality systems, coordinating quality management programs, and training personnel. The ideal candidate has a degree in a relevant field and experience in regulatory affairs. Strong skills in Microsoft Office and communication in English are essential for this role. Join a team dedicated to promoting quality and food safety culture.

Qualifications

• Candidate must possess at least a Diploma/Bachelor's Degree in a relevant field.
• 1-2 years of working experience in the related field is required or experience in regulatory affairs is an advantage.
• Strong analytical and problem-solving skills.

Responsibilities

• Maintain and update QMS documentation to ensure compliance.
• Coordinate tracking of quality objectives and management programs.
• Review and analyze non-conformities to propose improvements.

Skills

Proficient in Microsoft Office

Strong analytical and problem-solving skills

Good oral and written communication skills in English

Ability to work independently

Team player with continuous improvement mindset

Education

Diploma/Bachelor's Degree in Food Science, Food Technology, Pharmacy, Engineering, Biomedical Science or a related field

Tools

Microsoft Office

Job description

Maintain and update QMS documentation, including policies, procedures, manuals, and records to ensure compliance with ISO, HACCP, FSSC, and other relevant standards.

Support the integration and alignment of QMS and FSMS requirements across departments and production sites.

Ensure the renewal of product registration, certification, and maintain necessary record-keeping on regulatory related issues.

Coordinate and track implementation of quality objectives and management programs.

Ensure that all food safety systemCritical Control Points (CCPs)are properly aligned and tally with the HACCP process flow, hazard analysis, and product description for verification.

Review that CCP monitoring procedures, records, and corrective actions are implemented according to the HACCP plan, reviews and validation activities.

Ensure all documentations adheres to ISO standards and company procedures.

Develop, implement and manage document control procedures and protocols to ensure compliance with ISO standard.

Implement and maintain iso-related processes and system.

Ensure timely review and update of SOPs, forms, and records to reflect current practices and regulatory requirements.

Facilitate change control documentation for process or product-related changes impacting quality or food safety.

Ensure the CAPA (Corrective and Preventive Action) process by tracking progress, verifying implementation, and ensuring timely closure.

Ensure proper document control, maintenance and improvement of all ISO-related documentation.

Ensure proper documentation, tracking, and archiving of regulatory submissions and correspondence.

Review and analyze recurring non-conformities to identify systemic gaps and propose improvements.

To conduct and coordinate QMS-related training (e.g., Food Safety Principles, ISO awareness) and cross-functional teams.

Promote awareness of quality and food safety culture within the organization.

Ensure ongoing compliance with external certification standards such as ISO 9001, ISO 22000/FSSC 22000, HACCP, and other customer or legal requirements.

Ensure all food or cosmetic formulations and machinery comply with applicable local and international regulations, including NPRA, MOH, SIRIM, JAIS, JAKIM, DOSH, MITI, KPDN, MyIPO and the Food Act & Regulations.

Coordinate documentation and evidence submission during certification renewals or surveillance audits.

Identify opportunities for improvement in quality systems and operational processes.

Collaborate with Production, R&D, Purchasing, and QAQC teams to align operational controls with QMS and FSMS requirements.

Provide guidance to ensure consistent implementation of policies across from Production, R&D, Purchasing, and QAQC departments.

Participate and assist during internal and external audits when required.

Represent the Company when engaging with Government and Overseas Agencies when necessitating.

Support additional regulatory or compliance-related tasks as assigned by management.

REQUIREMENTS

Candidate must possess at least a Diploma/Bachelor's Degree, Post Graduate Diploma in Food Science, Food Technology, Pharmacy, Engineering (Bioengineering/Biomedical), Biomedical Science, Life Sciencesor a related field.

At least 1-2 year(s) of working experience in the related field is required for this position or experience in regulatory affairs within the medical device or pharmaceutical industry would be an added advantage.

Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

Good oral and written communication skills in English (additional languages an advantage).

Strong analytical and problem-solving skills; able to think critically and resolve issues independently.

Result-oriented, reliable, and able to perform well under pressure.

Strong team player with a continuous improvement mindset.

Trustworthy, resourceful, and demonstrates initiative in completing tasks.

Ability to work independently and collaboratively in a fast-paced, deadline-driven environment.

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