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RA and QA Assistant manager

Job Title: RA and QA Assistant manager
Contract Type: Permanent
Location: Hong Kong
Specialisation:
Ref: MS-181025-2
Contact Details: Mitsuhiro Sugimoto
Contact Email: mitsuhiro.sugimoto@jac-recruitment.com
Published: 17 days ago

RA and QA Assistant manager( Pharmaceuticals industry)

Our client is a Pharmaceuticals industry, seeking for the RA and QA Assistant manager for Hong Kong and Other asian country.

 

 Resposibility:

Collection of information on pharmaceutical administration, drug registration and laws and regulations concerning pharmaceutical affairs, etc. Provision of such information to relevant departments

Develop, update and implement the related Standard Operating Procedures (SOPs) on the regulatory and Quality Affair such as “Recall Procedure SOP”

Facilitate the application of Hong Kong product registration, licence renewal, import license, change of particular for registered product(s) including adding new indication

 Act as a coordinator for liaison with drug-related institutions such as regulatory authority, drug examination institutes, drug examination and evaluation centres.

Quality assurance updated with distributor

Regularly revise & update the SOP(s) to fulfil safety measures and maintaining the latest cGMP, GDP compliance

Product(s) quality checking when the shipment arrived and product release

Maintain Quality System updated in line with Global QA policy and QA system
 

 

 

 

Requirement:

Thorough understanding of the local regulations of RA, QA, PV

Knowledge of regulatory process

 Knowledge of ICH-GCP guidelines and international regulatory requirements such as PIC/S is an advantages

Cantonese, English

Interested candidates, please kindly send your detailed resume including:

 

mitsuhiro.sugimoto@jac-recruitment.com, jac.hk@jac-recruitment.com

 

1) Current and expected salary
2) Availability
3) Reason for leaving current and past employments

Personal data collected will be used for employment-related purpose only. We regret to inform that only shortlisted candidates will be notified, thank you.