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Department: Corporate R&D Quality Assurance 

Responsibilities:
To guarantee the compliance and the proper fulfillment of the Good Manufacturing Practices (EU and related annexes, CFR 21 part 210-211, ISO) within R&D Departments and Project Teams with focus on F-gas projects 

Activities:
• Participation in Project Teams
• Writing and review of Standard Operating Procedures
•  Batch record review related to Drug Product manufacturing
•  Review of Master Batch Record related to Drug Product manufacturing
•  Master Data and Bill of Materials approval into ERP (SAP)
•  Control specifications approval into LIMS
•  Change control, Out of Specifications, Deviations management
•  Review of GMP Protocols and Reports
•  Training execution on Standard Operating Procedures
 

Education: Life Sciences degree required (preferably Pharmaceutical Chemistry or Chemistry) 

Experience:
•  Quality Assurance experience within pharmaceutical Companies. Experience in R&D for IMP will be considered an added value 

Technical Skills: 
•  Good knowledge of EU-GMP, CFR 21 part 210-211, and ISO regulations, particularly applied to pharmaceutical development
•  Good knowledge of pharmaceutical development, particularly on clinical, technological and chemical development
•  Good knowledge of analytical techniques
•  Good knowledge of ERP, LIMS and EDMS systems
•  Good knowledge of training techniques
 

Soft Skills: 
•  Good time management, prioritization and organization skills
•  Ability to work in and collaborate in a team environment
•  Good interpersonal skills
•  Driving for results
•  Decision making
•  Good listening skills and assertiveness
 

Languages: good level of english

Type of contract Permanent  

Place of work: Parma, Italy