BASIC FUNCTIONS:
This position is responsible for maintaining and implementing the quality operation system to ensure the related activities comply with cGMP, ISO requirements, related regulatory and J&J Quality Policy.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1 Online monitoring for production area, identifying potential quality or safety risk, cooperating with corresponding area owner to address the findings. -- 20%%
2 Supporting Product release activities, including batch record preparation, product physical inspection and batch record review. -- 20%%
3 Handling Quality event/non-conformance, including quality event initiation, bounding, containment and correction/immediate action to reduce the production and quality system risk. -- 30%%
4 Participating and contributing as representative of quality operation in projects/validation activities and other continues improvement activities. -- 10%%
EDUCATION AND EXPERIENCE:
1. Master’s degree with min.1 year working experience in quality management or manufacturing of pharmaceutical/medical device industry.
2. Or bachelor’s degree with min.3 years working experience in quality management or manufacturing of pharmaceutical/medical device industry.
3. Or College Degree with min. 5 years working experience in quality management or manufacturing of pharmaceutical/medical device industry. Sterile production experience is preferred.
ESSENTIAL SKILLS AND ABILITIES:
1. Experience with quality control and GMP/ISO standard.
2. Good organizing and coordinating skill, good communication and interpersonal skills.
3. Familiar with quality tools(like Minitab, CPK)to perform data stat. and analysis.
4. Integrity and ethics.
3. Detail oriented.