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QC Facilitator

Plats Wuxi, Jiangsu Sheng, Kina Jobb-id R-097674 Datum inlagd 01/14/2021

Routine analytical control management

•      Organize daily analytical work for products and materials to ensure their accuracy and timeliness

•      Maintain and improve test lead-time in chemical lab

•      Review and approve test result

•      Develop or transfer test method for new material

•      Handle deviation and OOS case

•      Issue and update related SOPs

•      OOX Investigation

•      Analytical related trouble shooting

•      OEL test support

•      Fake medicine identification support

•      Reagent,reference standard and consumable management

Routine Management 

•      Lead analytical method development, transfer and validation.

•      Review and approve the in-house specification, test method and batch analysis record of starting materials and finished products

•      Review and approve the purchasing specification for starting materials.

•      Create, update, review and approve the relevant Guideline and SOP.

•      Introduction of advanced technology, and new tools/ideas to improve QC technical capability.

•      Support analysis of process validation

•      Stability study management

•     Analytical Instrument selection, purchasing, validation and maintenance.

•      OOX Investigation

•      QC System (GLMS, Empower, elab and CIMS, TOMS) management

•      Support other AZ sites that analysis related.

•      Analytical related trouble shooting

•      Regulatory and registration support

•      Internal and external GMP audit.

GMP compliance

•      Track the requirements for GMP, GLP, corporate standards or regulatory

•      Establish and maintain compliance system within finished group

•      Support self-inspection and coordinate audits from authority or WWAG

Training and development

•      Participate actively in serials training required to be held by internal and external.

•      Develop all kinds of skills in relation to work field and pursue continuous improvement

•      People and organization development to improve capabilities of QC staffs.

Special tasks for the person

•      Establish optimal operation pattern in chemical lab and build high efficient team to achieve department strategy and goal

•      Rational budgeting for lab resources, like investment, expenditure and headcount

•      Lab SHE management

•      Ensure good logistics for lab, e.g. keep reasonable stock for lab consumables

•      Support to global and international projects

•      Performance evaluation and control

•      Develop people

S.H.E. Responsibilities

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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