Regulatory & Quality Manager

Responsibilities and Duties

1. Responsible for establishing and enforcing policies to ensure the Company complies with the corporate quality policies, industry regulations and laws that apply to the businesses, including compliance to QMS, GxP (e.g. Good Manufacturing Practice [GMP], Good Distribution Practice [GDP] etc.) regulations.
2. To manage overall Quality within the Company and to ensure related activities adhere to regulatory requirements as well as corporate standards.
3. Responsible for the daily operations of Quality within the Company.
4. Responsible for application and renewal of permit and licenses required by the Company and be a licenses' holder.
5. Design, develop and implement Company’s overall quality management systems at all levels and ensure it is maintained.
6. Develop and implement clear and precise methodologies of validation to comply with prevailing applicable regulations.
7. Lead in the validation and qualification projects and processes of the Company.
8. Lead internal and external (customer, authority and supplier) audits and ensure timely closure of audit findings, if any.
9. Provide monthly KPIs and status reports on Quality initiatives to Management.
10. Lead/ Assist investigation on management systems’ non-conformity and follow-up on corrective and preventive measures.
11. Update regarding industry changes, trends, and best practices and assess the potential impact of these changes on organizational processes.

Knowledge and Skills Requirement

• Degree in Quality Management or equivalent.
• At least 4 - 5 years of GMP and GDP related experience.
• Strong knowledge about rules and regulations pertaining to the industry.
• Demonstrate leadership abilities.
• Excellent analytical and troubleshooting skills.
• Excellent problem-solving skills with ability to provide prompt resolution to problems.
• Good co-ordination and organization skills.
• Strong verbal and written communications skills.
• Supervising and delegating work to subordinates and ability to evaluate their performance.
• Proficiency in Microsoft Office.

Other Information:

• Working Hours: Monday to Friday (8.00am to 5.00pm)