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Primary FunctionTo assist QA Manager to conduct QA oversight within Wusi site, review and approve GMP documents to ensure that all aspects of manufacturing activities comply with cGMP legal and regulatory requirements and with the Elanco Animal Health Quality Standards.
Primary Accountabilities/Responsibilities- Perform review of GMP related documents (APIs and pesiticide batch records, raw material analytical record, etc.) to ensure batch release timely.
- Manage and oversee artwork activities.
- Manage and oversee pest control, environment, gases and water system monitoring activities including annual review preparation.
- Timely write and complete GMP relevant documents in own area: e.g. PQRs, annual environmental monitoring data review, etc.
- Conduct on-site QA inspection for formulation production and line clearance check, label printing confirmation, packing check etc.
- Timely perform container wise ID test.
- Act as site SAP Q power user backup.
Qualification - BS degree above in Chemistry, Pharmacy or relevant discipline Desirable: MS or equivalent
- At least 5 years experience in pharmaceutical or relevant industry (e.g. laboratory, manufacture and packaging).
- Experience in EU GMP and ICH guidelines and formulation is a plus.
- Experience in production is a plus
Skills & Knowledge
- Fluent in English and Chinese (both written and spoken).
- Excellent interpersonal skills and able to network effectively across groups and levels.
- Ability to work under pressure and compliance with strict deadlines.
- Ability to priorities or work with conflicting priorities.
- Advanced knowledge of MS Excel, Word, PowerPoint.
Core competencies
- Influence: Builds relationships and influences internal and external customers, Team player.
- Accountability: Accountable for Results, Good multiple-tasking focus, Strong follow through and closure of matter/case.
- Working Style: Persistence and Stability, Results Orientation, High learning agility, Proactive and fast response/having sense of urgency, , Attention to details and adherence to guidelines.
- Personal Brand: Resourceful, Assertive, Self-motivated, Energetic.
Other Information
1. Location: Wusi Site
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status