QA Manager
Famour local pharmaceutical manufacturer
Long An
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 their jobs 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 is preferred.
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Industry:
Pharmaceutical
Job Category:
QA / QC
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Location:
Long An
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