To provide delegation and support for all initiatives concerning compliance improvement activities, aimed to enhance the cGMP and GDP practices in Manufacturing area.
To actively liaise with relevant PICs in Manufacturing and external stakeholders to devise realistic action plan aimed to close the gaps of non-compliances in Material & Finished Goods Warehouse; and the subsequent tracking of the execution
To lead and execute the internal walkabout and compliances audits at the Manufacturing site, and to discuss with individual PICs on the findings for closure.
To develop, maintain and track the execution of all training needs analysis and training plans for Manufacturing staffs.
To review, monitor and continually update the risk and gap assessment of the routine operation in Manufacturing area; and to follow up with the treatment execution for closure.
To support and coordinate all preparation work in documentation and housekeeping of the Manufacturing team in response to planned and unplanned major external audits
To undertake pertinent compliance improvement project, in line with company’s business and quality direction.
Minimum Working Experience
Second Class Upper
Possess a recognized Bachelor Degree preferably in Science / Engineering field.
Minimum 1 to 3 years of experience in pharmaceuticals industry.
Good understanding on production processes such as manufacturing of oral solid dosage form, liquid, creams and softgels.
Good communication, management and report writing skills.
Good understanding and ability to interpret regulatory guidelines (PIC’s/TGA/FDA/EMA)
Basic understanding of Critical facility such as HVAC, water system, Sterilization system, equipment qualification and compressed air.
Good interpersonal and leadership skills, good planning and organizing / management skills, good communication and analytical skills, good efforts and initiatives, good attitude and discipline, integrity, independent, self-confidence, conceptual and analytical ability, achievement