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Quality Specialist
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Support, Engineering
Projektbeschreibung
The Role - Quality Specialist
Type - start ASAP until the end of 2015
Location - Co. Tipperary
Our key client, a global pharmaceutical leader, is in need of a Quality Specialist, to support their API and New Product Formulation areas of one of the facility in Ireland.
Key Responsibilities:
The QA Specialist will be responsible for all aspects of Quality Assurance including internal auditing, annual process reviews, ensuring compliance with regulatory requirements, review of pre- and post-processing documentation, review of validation and qualification documentation, GMP and compliance training and will also be involved in leading quality improvement projects.
The position involves participating as functional expert in the cross functional team that manages production of API/Formulated Products.
Investigation and approval of deviation events, support of Laboratory out of Specification investigations and identification of appropriate CAPAs.
Participating in the site audit system by conducting system and walkdown audits.
Conducting pre and post review and approval of Process and Cleaning Records.
Preparation of Annual Product Reviews is also a key aspect of the role.
Key Requirements:
Bachelor or Masters degree in a Science or Engineering discipline.
Experience in one or more of the following areas in the pharmaceutical/chemical industry is required:
Quality function
Laboratory Analytical function
Product development
Technical services
Demonstrated leadership and teamwork skills, excellent analytical and problem solving abilities, proven written and verbal communications skills
Type - start ASAP until the end of 2015
Location - Co. Tipperary
Our key client, a global pharmaceutical leader, is in need of a Quality Specialist, to support their API and New Product Formulation areas of one of the facility in Ireland.
Key Responsibilities:
The QA Specialist will be responsible for all aspects of Quality Assurance including internal auditing, annual process reviews, ensuring compliance with regulatory requirements, review of pre- and post-processing documentation, review of validation and qualification documentation, GMP and compliance training and will also be involved in leading quality improvement projects.
The position involves participating as functional expert in the cross functional team that manages production of API/Formulated Products.
Investigation and approval of deviation events, support of Laboratory out of Specification investigations and identification of appropriate CAPAs.
Participating in the site audit system by conducting system and walkdown audits.
Conducting pre and post review and approval of Process and Cleaning Records.
Preparation of Annual Product Reviews is also a key aspect of the role.
Key Requirements:
Bachelor or Masters degree in a Science or Engineering discipline.
Experience in one or more of the following areas in the pharmaceutical/chemical industry is required:
Quality function
Laboratory Analytical function
Product development
Technical services
Demonstrated leadership and teamwork skills, excellent analytical and problem solving abilities, proven written and verbal communications skills
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges