Scope?Be respoible for coordinate the generation, review, formatting and publishing of Chinese IFU.

?Participate in quality related affai, include internal/external audit, SOPs, training system.

Respoibilities?All employees must take reasonable care for his/her own safety and for the health & safety of anyone else who may be affected by his or her acts or omissio at the workplace.

?All employees must cooperate with his or her employer with respect to any action taken by the employer to comply with any requirements imposed by or under the OH&S Act, such as reporting of hazards and accidents, using supplied protective clothing and equipment and using safe work practises.

Tasks?Coordinate review, formatting and publishing of Chinese Itructio for Use (IFUs)

? Control and assign veioning of each Chinese IFU.

?Write and route change requests necessary to introduce or update IFU

?Maintain relevant electronic data.

?Support quality manager to maintain and improve quality system compliance in following sectio:

a). Document Control: Issue and distribute the hardcopy of current veion; collect and destroy hardcopy of obsolete veion in time

b). Provide document coultation, query and scan from internal or external custome.

Collect quality related records by requirements of related SOP and establish list of the records;

c). Participate in internal and external audit.

d).Maintain the change control system including procedure establishment and improvement, training and spread procedure

e). Maintain CAPA procedure and provide the training for othe.

f). Maintain NC procedure and provide the training for othe

g).Conduct internal audit as an auditor. Prepare specific audit plan for specific function, conduct audit, generate the finding, review and follow action plan

h).Coordinate the preparation of annually quality training plan.

i). Routine monitor in warehouse (if necessary): temperature / humidity calibration record, pest control record.

j). Handle routine quality system management procedure in operation process in DC, such as NC, CAPA

k). Handle routine quality & operation procedure in DC. Such as product release, goods ipect.

l). Maintain quality training procedure and provide the training for othe.

m). Other respoibilities defined in written procedures.

Experience?Relevant college/univeity degree is essential.

?2-3 yea’ experience in quality system management in medical device or pharmaceutical industries.

?English fluent in writing, reading, listening and oral.

?Familiar with office software.

Peonal attributes?Good communication skills are required.

Self ?Maintain professional conduct at all times.

?Maintain confidentiality at all times.

?Maintain integrity all the time