Key responsibilities
-
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.
Qualification:
-
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.
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.