QUALITY ASSURANCE MANAGER @ Kotra Pharma (M) Sdn Bhd

QUALITY ASSURANCE MANAGER Kotra Pharma (M) Sdn Bhd

Kotra Pharma (M) Sdn. Bhd. is a wholly owned subsidiary of Kotra Industries Berhad, a company listed on the Kuala Lumpur Stock Exchange. KPM is one of Malaysia’s leading pharmaceutical manufacturers.

As a result of the company’s expansion plans, we are looking for qualified candidates with excellent organization skill, resourceful, independent and good command of English to join us in the following position:-

QUALITY ASSURANCE MANAGER ( Based in Malaysia )

Location: Based in Melaka, West Malaysia

JOB SCOPE:

Report to the General Manager (Plant Operation) on all matters related to the Quality Management System, Documentation, Training, Calibration, Validation and Compliance.
Appointed as the Management Representative with the responsibility in ensuring the requirements of ISO 9001:2000 are effectively implemented and system maintained to meet the business objectives of the company.
Responsible for the implementation of an Effective Quality Management System in accordance to current Good Manufacturing Practices based on PIC/S, BE EN ISO 9001:2000 and current technological requirement in pharmaceutical manufacturing and quality control.
To conduct the management review meeting and ensure timely closure of the items discussed.
Responsible for the Internal Quality Audit Program, Vendor Audit Program and third party audits in the event of contract manufacture of any Kotra product.
To manage the GMP training program and ensure GMP compliance at all time.
Responsible for managing and coordinating the compliance audit by NPCB and other Regulatory bodies from other countries.
To completion of OSS and review final report.

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