- Following good documentation practice to build up and maintain sustainable quality system, guide and supervise the implementation, to ensure NNSH GSP complies with local GSP requirements and global quality standards.
- G uild relevant departments and personnel to enforce laws, regulations and GSP drug management;
- Organize the formulation of quality assurance system documents, guide and supervise their implementation;
- Be responsible to verify the legitimacy of drug suppliers and distributors , the legitimacy of purchased drugs and the legal qualifications of sales personnel of drug suppliers and procurement personnel of distributors and conduct dynamic management according to changes of subjects for verification;
- Be responsible for the collection and management of quality information and establish drug quality archive;
- Be responsible for the inspection and acceptance of drugs, guide and supervise quality control activities for such processes as the procurement, storage, maintenance , sales, refund and transportation of drugs;
- Be responsible for the confirmation of unqualified/ rejected drugs and supervise the process of relat ed drugs;
- Be responsible for the investigation, handling and reporting of quality complaints, deviation and quality incidents;
- Be responsible for the reporting of fake and inferior drugs;
- Be responsible for drug quality inquiry;
- Be responsible to guide the configuration of quality control function in IT system;
- Be responsible for the review of IT system operating access and the creation and update of master data for quality control;
- Organize the validation and calibration of relevant facilities and equipment;
- Be responsible for the management of drug recall
- Be responsible for the reporting of adverse events of drug;
- Organize the internal evaluation and risk assessment of quality control system;
- Organize the investigation and evaluation of quality control system and service quality of drug suppliers and distributors ;
- Organize the review of transportation conditions and quality assurance capabilities of carriers;
- Assist in the conduct of quality qualification , education and training;
- Other duties to be performed by quality control department or assigned by supervisor.
- Bachelor degree or above in pharmacy, biology, chemistry, medicine or other related area.
- Licensed Pharmacist. ( mandatory)
- Above 5 years quality management experience in GSP area.
- Good English skill at reading, writing, listening and speaking.
- Good communication skills of both scientific and non-scientific information.
- Professional knowledge in local regulations.
- Problem solving ability and skills.
- Ability to face challenge and self-learning.
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Drug Quality Leader - Shanghai, 中国 - Novo Nordisk A/S
描述
Key responsibilities
Qualification:
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
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