You should be responsible for:
- Organize to define quality system, guide and supervise the implementation, to ensure company complies with applicable RD Quality Standards and local regulatory requirements.
- Act as Local safety officer, ensure local case management and global product notification implementation fulfills global standard and local regulation. And report advert events and recall to local authority according to local regulations.
- Act as AQH, communicate, train and monitor on RD Divisional Standard’s local implementation.
- Coordinates and supports for External Audit, Internal Audit.
- Monitor and report on local regulation changes and its impact together to company.
- Handle complaint management, training on process, system and global document; classify PRI, AE report according to local regulation.
- Global product notification (QN& SBN) communication, execute, contact local authority.
- Establish and maintain the good relationship with key contact. Recommend valuable suggestion to company.
- Communicate, train and monitor local implementation of applicable Divisional Standard.
- Lead QA team to assure local relabeling, company permit maintains, supply chain, distributor management, promotion materials review, guide on GxP related content in computer system, etc. to comply with RD quality and local regulatory requirements.
- Quality Documents & Records Control and Change Control. Keep records. Have clear filing and maintain of all documents.
- Coordinate and support for External Audit, Internal Audit.
- Other projects or tasks assigned by line manager.
- Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection.
- Understand and fulfill the responsibility of line manager's SHE tasks and duties (as defined in SHE handbook).
You should have:
- Bachelor degree or above, subject on Medical/bioengineering/ clinical Medicine or biochemistry; license pharmacist or laboratory technician-in-charge preferred
- Proficiency in both spoken and written English
- Good command of MS office software application
- Understand medical device regulation
- Have above 10 years’ experience, especially in QA management, GSP and ISO certification
- According to the "Quality Management Regulations for Medical Device Management" and the "Regulations on Quality Management of Pharmaceutical Products", health checks should be conducted at least once a year; if you have infectious diseases or other diseases that may contaminate medical devices or drugs shall not be engaged in related work.
罗氏是一家提供均等机会的雇主。Quality、 Quality > Quality Assurance