YOUR TASKS AND RESPONSIBILITIES

• Provide professional expertise enable quality subject, issues, system in to daily operation and Proactively communicates HSE issues, risks, status
• Identify opportunities for continuous improvement and the implementation of best practice principles, to enhance quality system performance maturity level
• Quality initative proposal, implementation to ensuring that performance confirms and beyond established standards
• Establish lessons learned program to ensure continues improvement and knowledge inherate
• Driving optimization E2E operation working process (process map) prevent risk occurrence and satisify customers
• Responsible for regulatory compliance relevant activities, included CMC dossier/variation preparation, file compliance check, regulatory relevant assessment to ensure the product quality, safety and compliance.
• Build investigation capabilities at shop floor level and enhance the various quality tools used to identify root causes and appropriate CAPAs.
• Oversight GMP practice & Operation potential risk identification and mitigation via GEMBA, and Lv. Dialogues and Work with business partners to review identified risks for root cause, impact and recurrence, and ensure that relevant line function owners implement mitigation plans. Ensure that issues are escalated to the relevant functions in a timely manner, as needed.
• Govern GMP Site License management, audit management to ensure compliance.
• Review/approval procedures (SOP, protocol, Report, Change, etc.)
• Handle customer complaints, supplier complaints, material status, quality issues etc.
• Shopfloor capability & culture advancing through. BP establishment, share, training, coach, quality trigger, BBQ, etc.
• Define and enforce quality gates and criteria that must be met for critical process, eg. Change control, Deviation, Validation/Qualification, Release

WHO YOU ARE

• Bachelor’s degree or above in Pharmacy or related disciplines.
• More than 6 years experience in the pharmaceutical industry in a relevant field such as quality, pharmacovigilance or a directly related area, at least 4 years in quality assurance role.
• Familiar with local/ International GMP and regulations requirements.
• Soft Skills:
• leadership / corporation skills. Data analytical, problem-solving, and decision-making abilities.
• communication, presentation, and interpersonal skills to effectively collaborate with teams Fluent English in written and in reading and spoken

隐私保护提示：拜耳深知个人信息对您而言十分重要，并严格遵守法律法规，竭力保证您的个人信息安全。如果您投递简历，您的简历及其他您主动提供的个人信息将被录入拜耳招聘系统，敬请知悉。