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