Validation Lead 工厂验证 (临港)

该职位来源于猎聘 Validation Lead , E2E Process Department: Technical Location: Shanghai Lingang Site / 上海临港工厂 Key Responsibilities ---- Accountable for oversight, management, and delivery of all Validation Lifecycle components (E2E: pilot scale to tube filling) ---- Involved in process risk assessment and scale up strategy discussion in early stage, like communicate with scientist once formula locked, and process development in pilot stage. ---- Development and lead the validation master plan (VMP), especially to validate the mixing process, packing & filling process, cleaning & sanitizing process robustness to make sure everything is regulated, under control and run smoothy on the production scale. Also, track and support facility validation, computer & document system validation to make sure the VPM completion. ---- Collaborate with cross functional teams like Manufacturing, Quality, Engineering and Process development to keep everyone’s on the same page, provide necessary training to production operators, and generate the final validation report;

Support internal and external audit. ---- Understands and ensures compliance to evolving expectations of:

• Equipment and Facility Commissioning & Qualification
• Process (Scale Up, Compounding) & Packaging (Tube Filling / Sealing) validation

Cleaning validation

• Continued Process validation (CPV),
• Analytical Method validation,
• Computer System validation ---- Collaborates across Engineering, Quality and Technical departments to ensure validation activities are completed on time and compliant to Haleon standards ---- Ensures that the site can demonstrate system compliance to a regulatory auditor, (e.g., FDA, Health Canada, or ANVISA) ---- Maintains site validation master plan (SVMP) Knowledge/Education/Experience Required ---- BS degree in engineering, industrial pharmacy, chemistry, or other appropriate scientific or pharmaceutical discipline. ---- Minimum of 5 years of demonstrated experience FDA regulated technical role, with strong experience in manufacturing technical process