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.
Junior External Manufacturing QA Manager
YOUR TASKS AND RESPONSIBILITIES
- Responsible for QA management and QA oversight of processes and products of the assigned portfolio including quality and regulatory requirements, prioritization, problem solving and escalation to Sr. Management, while assuring/ monitoring the quality performance of third-party contractors by tracking respective quality KPIs.
- Designated QA key contact to the assigned third-party contractors thus holds expert knowledge for processes and products of assigned portfolio.
- Interacts directly with third-party contractors and acts as quality interface towards other PS functions.
- Responsible for QAA management including negotiations and disputes
- Manages teams across functions to provide highly scientific evaluation of issues, including approval of deviations, changes, quality documentation etc., intended to mitigate quality and compliance risk while maintaining product supply
- Supports/manages Q-topics related to product launches/transfers with regards to quality requirements and their implementation.
- Maintains awareness of current GMP trends and manufacturing processes and supports continuous improvement of the product quality
- Assures regulatory and cGMP compliance with approved dossiers and provides support for regulatory agency inspections and requests
WHO YOU ARE
- Universty degree or above
- 2-3 years of professional experience in a Quality environment in manufacturing or development of pharmaceutical or biotech products or an equivalent combination of education and experience
- Knowledge and experience in pharmaceutical subject matter areas including: Manufacturing of bulk, intermediates and final containers; Product inspection and labeling; QC testing; Product disposition and release; Deviation management; Change management; Contract manufacturing
- Experience in oversight of contract manufacturing is preferred
- Broad cGMP experience and knowledge, QA/QC and regulatory compliance (US and other international agencies)
- Ability to streamline business processes to maximize efficiencies to resolve discrepancies and trending issues
- Ability to effectively manage multiple, complex priorities and to work cooperatively in teams and peer relationships
- Good leadership, drive results and motivate others to achieve corporate, site, and departmental objectives
- Serves as a liaison with regulators, internal auditors or external clients
- Proficiency in spoken and written Japanese as well as English language
- Proficiency in Microsoft Word/Excel/PPT applications
■The working location is either in Osaka orTokyo.
HOW TO APPLY
Please apply for the position through our recruiting website with Japanese resume, Japanese working experience and English CV.
Please find other working conditions at our career site, by coping and pasting the following URL on your internet browser.
Reference Code: 454921
Functional Area: 品質