Sr. QA Specialist - GMP
Location: NetherlandsThe Company
.Role Description
In this role you will make sure that that the company is compliant to EU legislation and you will be making the quality processes more efficient.Responsibilities
-Working with the site validation teams providing guidance in the strategy, planning, delivery and retirement several systemsReviewing and approving cGMP documents
Approving investigations assuring they are complete, accurate, technically justified with the required documented evidence including risk assessments
Managing, evaluating and approving changes assuring they are compliant
Tracking the overall status of all quality systems
Participating in the development/ revision of company policies/ guidelines/ procedures and implementation in the site;
Preparing and/ or reviewing performance metrics for quality systems
Requirements
Bachelor’s degree a life sciences related fieldAt least 7 years of experience
Knowledge of regulations in Production, Validation, Quality Assurance/ Control, Quality Systems
Knowledge of and experience with quality and compliance guidelines and manufacturing processes;
Self-starter and independent
Ability to influence co-workers and stakeholders
Fluent in both Dutch and English
Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Seppe Verhoeven
Job Description
The Company
.Role Description
In this role you will make sure that that the company is compliant to EU legislation and you will be making the quality processes more efficient.Responsibilities
-Working with the site validation teams providing guidance in the strategy, planning, delivery and retirement several systemsReviewing and approving cGMP documents
Approving investigations assuring they are complete, accurate, technically justified with the required documented evidence including risk assessments
Managing, evaluating and approving changes assuring they are compliant
Tracking the overall status of all quality systems
Participating in the development/ revision of company policies/ guidelines/ procedures and implementation in the site;
Preparing and/ or reviewing performance metrics for quality systems
Requirements
Bachelor’s degree a life sciences related fieldAt least 7 years of experience
Knowledge of regulations in Production, Validation, Quality Assurance/ Control, Quality Systems
Knowledge of and experience with quality and compliance guidelines and manufacturing processes;
Self-starter and independent
Ability to influence co-workers and stakeholders
Fluent in both Dutch and English
Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Seppe Verhoeven
Additional Information
- Last updated
- Employment type
- Full time
- Contract type
- Self employed
- Number of vacancies
- 1
- Min. experience
- Two years
- Min. education
- Bachelor
- Industry / category
- Jobs in Quality Control / Production Audit