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QA Manager

cap NA Topjobs' client

Famour local pharmaceutical manufacturer

location Long An

post time Posted 46 months ago

 Job Description

Ensure compliance to all WHO-GMP and PIC/s-GMP regulatory requirements

Manage Quality Control and Quality Assurance operations to ensure Euvipharm products meet all quality requirements with cost efficient and on-time supply.

Ensure that company has a smooth transition to P!CIS compliance. IdentifY and close all compliance gaps. Provide advice and direction to all departments in the company regarding quality issues.

Monthly report to the Board of Directors , as  well as the Quality and Technical Director regarding to progress and developments in project

Oversee the operations of the Quality Control and Quality Assurance departments. Make sure the departments  have  the resources (human and equipment) needed to meet  their J(Pls prescribed in quality processes. This includes testing and batch release times, as well as timely management of the change control, document control and validation functions.

Train and op staff across the company in GMP. Assist in development and deployment of training packages such as basic GMP and GLP, sterile manufacture, auditing GMP, and specific tops as required by the company.

Ensure that staff have access to sufficient training at a sufficient level of competence to perform theirjobs correctly. 

Take a part in the process of identifYing and resolving problems with products. Assist with liaison between Euvipharm and regional technical assistance where required

Assist  with  liaison  between  company 's Quality  Assurance   team  and  the  regional

team in Sydney.

 Ensure that company is meeting commitments on its GMP license regarding product safety, efficacy and quality. Oversee internal and external audits, product reviews, investigations, customer complaints, adverse events and product recalls. Make sure this information is used effectively to improve company 's GMP compliance

Ensure that there are no "critical "findings in external audits.

Requirement :

Bachelor of science, mqjoring in Chemistry, Biology or related field, or bachelor of pharmacy.

 Minimum 10 years of experience working in the pharmaceutical  industry (GMP), preferably  in a quality department (QA/QC)

 

 Minimum 5 years of experience in a supervisory or management position, preferably in a quality department (QAIQC).

 Staff Development Abilitie

 

 Ability to train and develop staff in GMP environment.A strong understanding of statistics as applied to manufacturing and laboratory processes ispreferred.

 

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company detail


300-400


Pharmaceutical


QA / QC


Full Time


Long An


English


Manager


English


53/7 Nhieu Tu St., Ward 7, Phu Nhuan Dist., HCMC


Ms Lan Phuong


08 62926671


phuong.lan.nguyen@natopjobs.com.vn quynhthu@lp-a.com.vn recruitment@natopjobs.com.vn lanphuong@lp-a.com.vn