YOUR TASKS AND RESPONSIBILITIES
- Work as QP to perform batch release, ensure release is implemented within leading time.
- Provide to the site Quality Head and leadership team an overview of the situation in regards of Quality Operations with the level of details and frequency susceptible to enable decision making.
- Participate in the site level projects as the contact window from Quality Operation in close collaboration with cross-function team internally and externally.
- Lead the QA operation team co-located at site workshop, QC laboratory, warehouse, and utilities, and timely provide quality comments, in case of deviation happen during production process. As escalation point to lead complex problem shooting in the daily work.
- Responsible for all site validation programs and coordinate with involved departments to ensure site validation lifecycle management procedures are established and implemented according to Chinese &EU regulations and Bayer CMS requirements;
- Lead site CAPA system management, including CAPA initiation, follow up and close in time
- Maintain deviation system to comply with Bayer CMS and cGMP requirements. Ensure deviation investigation is processed, reviewed and approved in a timely manner. Responsible for the deviation and complaint review board meetings.
- Acquire and maintain knowledge of current local and international regulatory requirements and trends to ensure that expert advice and appropriate technical support on GMP operation activities.
- Together with Head of Quality to provide direction and assist with making decisions that ensure the efficient operation of the business.
- Ensure any product quality/supply issues are communicatedtimely to management as required and are remediated appropriately.
- Continuously find the area of improvement to contribute to savings and productivity.
- Participate production level meeting and provide feedback from QA perspective.
- Provide mentoring and coaching to operation QA team.
- Participate in HSE trainings. Follow operational procedures. Report safety concerns and report safety proposal
WHO YOU ARE
- Bachelor or above, major in chemistry/pharmacy or other related areas.
- Experience: 10 years or more working experience within biotechnology or pharmaceutical, minimum 5 years of experience in quality.
- Strong technical expertise and familiar with China and global GMP regulations
- Solid experience in people management
- Fluent English in written and in reading and spoken
- Preferred to have working experiences in multinational company with strong GMP consciousness.
- Excellent leadership and communication skills and ability to work in local and global cross functional teams.
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