•Author production documents, i.e. Batch sheet, EBPR, Forms, SOP, OCM, Validation protocol/report, etc.
•Design and conduct qualification, process validation and cleaning validation.
•BOM/recipe in SAP if applicable.
•Handle problem solving or technical investigation for issues to enable process robustness.
•Drive continuous improvement of process robustness.
•Lead product/process ownership, incl. CPP, CMA, CQA and CPV, etc.
•Support new technical project to ensure deliverables to plan, incl. material source change, technical transfer, line expansion, capacity uplift, etc.
•Act as technical personnel to support capability uplift of process、manufacturing and quality team
•Work with internal and external stakeholders to manage technical affairs that are assigned by line manager.
•University graduate or above
•Familiar with Pharmaceutical knowledge and experience, including production processes, validation, trouble shooting, investigation, and continuous improvement.
•Knowledge of specific dosage forms.
•Oral Solid Dosage knowledge required for formulation process engineer;
•Sterile/aseptic process and microbiology knowledge required for sterile process engineer;
•Blister & bottle packing, etc. knowledge required for packing process engineer;
•GMP and regulatory knowledge
•Familiar with the knowledge of process and cleaning validation
•Excellent written/oral English
•High level of computer skills
•Basic statistical knowledge
•Knowledge of GMBR/PVL/PMBR (if applicable)
•At least 3 years’ experience in pharmaceutical process.
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.