At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
Validation and GMP Inspection Supervisor -验证与自检主管
YOUR TASKS AND RESPONSIBILITIES
- Update site VMP and maintain VMP database routinely, manage Sys. No., track the progress of qualification and validation execution.
- Is responsible for creating periodic qualification documents, coordinate departments for execution. Participate in review Q&V protocols and reports from compliance perspective, especially enhance the management to process validation and cleaning validation as new requirements from up-to-date GSOPs and guidances.
- Enhance qualification management of site self-inspectors and provide related training, enhance self-inspection's scope and extent, enhance the CAPA management.
- Provide dedicate trainings periodically at site level about those findings from self-inspections and qualification&validaiton.
- Add the on-site inspection of qualification and validation during execution, enhance the documentation management.
- Participate or organize related departments to do risk assessment when there is upgrading of current systems or new technical system.
- Organize Third Party to perform site monitoring and maintainence of pest control, coordinate departments for deviation investigation about pest control if applicable.
- Update SOP according to GSOP and local requirements; some related work like, to review monthly maintenance report.
WHO YOU ARE
- University graduate or above in pharmacy or related major
- 5 years and above in quality department, or experience for implementation of qualification and validation
- Proven time management and communication skills.
- High degree of autonomy in tasks, but team-worker and good skills in cross-functional work relationships
- GMP/regulations, Pharmaceutics and qualification/ validation related
- Knowledge of GMP standards and related national / international regulations and guidelines.
- Knowledge of production process and quality control.
- Good at computer operation.
- Fluent Spoken and good written English.
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Reference Code: 347302
Functional Area: 质量