Have the ability to perform the following tasks:

Leading and managing the cGMP QC, Production, QA teams to ensure compliance with quality standards and regulatory requirements;
Developing and implementing strategies for the timely and successful approval of new vaccine products by regulatory agencies and meeting the quality requirements of the organization;
Ensuring compliance with cGMP regulations and other relevant quality standards and maintaining up-to-date knowledge of these regulations and standards;
Collaborating with cross-functional teams to ensure that all aspects of vaccine development and production, including manufacturing, quality control, and testing, are in compliance with quality standards and regulatory requirements;
Overseeing the implementation and maintenance of quality systems, including documentation, record-keeping and training;
Managing relationships with external partners, including contract manufacturers, vendors and regulatory agencies, to ensure compliance with quality standards and regulatory requirements;
Involved with the continual improvement program of the facility;
Manage Technology transfer internally and externally; and
Staying up to date with the regulatory requirements and industry trends.

Qualifications and Experience:

Malaysian citizens;
The minimum qualification of a Degree in the field of Scientific/Engineering or a related field and recognized by the Malaysian government from a local or foreign higher education institution or a qualification recognized as equivalent;
Candidates with a master's degree or PhD academic qualification is an advantage;
At least 5 years of experience in supervising, maintaining the status of GMP status and managing the performance a Bio/Pharmaceutical cGMP facility;
Excellent leadership and communication skills, with the ability to effectively manage and mentor team members;
Must know and be familiar with regulatory requirements but not limited to such as PICs, WHO guidelines, and ICH requirements;
Must possess significant technical expertise in GMP operations within both Primary (API) and secondary operations as well as strong evidence of complex technical problem solving;
Must attend and be familiar with regulatory investigations and audits e.g., NPRA, FDA and other relevant authorities;
Experience in packaging, inspection, and storage of GMP-manufactured products are added advantage; and
Understanding of GMP area facility and utility maintenance Sterility assurance program, GMP equipment engineering, Validation and warehousing for cGMP-related materials and products are added advantages.

For more info, please visit our website: https://nibm.my/v6/?page_id=135

Closing Date: 10 JUN 2024

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