- Candidate must possess at least a Bachelor Degree, Post Graduate Diploma, Professional Degree, in Mechanical Engineering or Mechatronics Engineering or equivalent.
- Candidate age should be between 30 ~ 39 years old with excellent health condition
- Required language(s): Bahasa Malaysia, English.
- Vast experience in pharmaceutical and medical devices products manufacturing environment with proven track records.
- Able to operate personal computers with knowledge in Microsoft Office. Knowledge in computerized company operation and management system is essential.
- Excellent communication and interpersonal skills.
- Applicants must be willing to work in Kota Bharu and willing to be relocated or assigned to subsidiaries within Malaysia or overseas.
- Oversees the overall process (Manage, Plan, Organize, Direct)– keeping up date to internal, external and international rules and regulations pertaining to manufacturing, selling and shipping of goods.
- Managing the update of quality documentation based on the process requirement on a recognized standard and practice such as internal SOPs, cGMP, ISO Standards published by the International Organization for Standardization, Medical Device Regulations, Halal Pharmaceutical Standard MS2424 and other industry specific manuals and protocols.
- Leading the Quality Management and Compliance team in carrying out the detailed assessment review of products quality and their components at different stages of production by providing training for executives and supervisors, providing documented quality standards as guidelines, quality inspection tools and software to support the operation.
- Oversees the coordination of work with the product development team or Research & Development team to establish quality standards and specifications.
- Manage proper coordination work with Procurement team or Supply Chain team, suppliers/vendors to formulate quality standards for the goods. To ensures that incoming components and materials will comply with the company’s quality standards (related to no.1 & 2 above), minimizes the time and cost of inspection, and contributes to the quality of the finished product. Any deviations must be detected and immediately corrected.
- Responsible for the coordination of validation program, change control and deviation management.
- Responsible for periodic vendor audit.
- Responsible as authorised signatory for product release.
- Manage & coordinate proper communication, arrangement regarding arising compliance issues, audit matters with the local and international Regulatory Compliance authority.
- Review the quality data and recommend changes to production processes or quality controls to eliminate the problem, to identify trends of quality problem and coordinating the development of continuous improvement programs.
- Manage and facilitate the departmental operation needs in terms physical equipment & tools, manpower and to ensure the departmental budget to be in line with the company’s overall budget.
Perks & Benefits
- Commission and bonus
- Allowance (travel stipends, transportation, etc.)
- Nearby public transport
- Medical insurance
- Work visa sponsorship
- Personal leave
- Personal development opportunities
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