Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
QA Specialist (Commercial QA)
YOUR TASKS AND RESPONSIBILITIES
Responsible for local user access as PSI (Process and System Integration) key users to manage and approve QM authorization in SAP system for GSP (Good Supply Practice).
Take QA role in SSM (SAP Solution Management)system to approve relevant CRT (Change Request Ticket) and carry out the relevant test responsibility as necessary.
Manage quality master data and create product inspection plan in SAP system for drugs and medical devices.
Perform the oversight of local user of global digital system (e.g. Lifedoc, Dev@com, AIDa, valGenesis, and etc.)
Responsible for developing and monitoring of document management processes in order to comply with the principles of GxP requirement.
Perform oversight for archiving document and record, monitor the retention list and record to assure all documents can be retrieved easily whenever.
Coordinate local QRM (Quality Risk Management) Team to assess, control, review and communicatequality risks for commercial quality operations.
Revise/review related SOPs to ensure the procedures continuously complied with the regulation requirements.
Perform other duties and special assignments as directed by QA manager.
WHO YOU ARE
Experience: More than 3 years working experience in multinational company with strong GMP/GSP consciousness
Education, Knowledge & Skills:
• Bachelor or above in pharmacy/chemistry or other related areas
• Quality IT system experience (e.g. SAP)
• Excellent communication skills especially the ability to work with
local and global cross functional teams
• Good communication skills in English (oral and writing)
• Licensed pharmacist is preferred.
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: 453726
Functional Area: 质量