Quality Systems and Improvement Lead
Titel: Quality Systems and Improvement Lead
Werkgever: Hays
Plaats: Provincie Noord-Brabant
Provincie:
Locatie:
Provincie Noord-Brabant /
Omschrijving:
Your new company
Multinational pharmaceutical company in North Brabant
Your new role
In this temporary role you will be in lead of the QSI (Quality Systems & Improvement) group. The group consists on about 8 employees whose main responsibilities are: Ensure cGMP compliance of Biotech Operations (cGMP training & audit function) QMS and site compliance plan Ensure Biotech Licenses, GMP certificates and Site Master File are maintained Connected to Global Compliance Governance of improvement initiatives portfolio Coordination of business process improvements Document Management Site Record Management Liaison The focus for the next 6 months is to improve BT's compliance level to successfully execute an FDA Pre PAI inspection in Q2 2016, while undergoing greatly challenging business processes (SAP implementation, ambitious manufacturing schedule). The candidate we are looking for has proven experience with FDA inspections and gap analysis.
What you'll need to succeed
You have at least a university degree in Biotech/Bioprocessing or equivalent of minimal 5-7 year experience in pharmaceutical industry of which 3 years experience in quality. Strong project management skills & proven ability to manage complex projects, the willingness to certify for or possessing Black Belt degree. In addition Passion for Lean and Continuous Improvement and a good command of writing and speaking in Dutch and English • Percentage in service 100%
What you'll get in return
A challenging role within a multinational function which gives you the opportunity to translate global guidelines within de sites in the Netherlands and development as a multi-disciplinary leader.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
Interesse?
Stuur ons dan je CV en motivatie toe door te klikken op onderstaande knop "Reageer op deze vacature".
Provincie Noord-Brabant /
Omschrijving:
Your new company
Multinational pharmaceutical company in North Brabant
Your new role
In this temporary role you will be in lead of the QSI (Quality Systems & Improvement) group. The group consists on about 8 employees whose main responsibilities are: Ensure cGMP compliance of Biotech Operations (cGMP training & audit function) QMS and site compliance plan Ensure Biotech Licenses, GMP certificates and Site Master File are maintained Connected to Global Compliance Governance of improvement initiatives portfolio Coordination of business process improvements Document Management Site Record Management Liaison The focus for the next 6 months is to improve BT's compliance level to successfully execute an FDA Pre PAI inspection in Q2 2016, while undergoing greatly challenging business processes (SAP implementation, ambitious manufacturing schedule). The candidate we are looking for has proven experience with FDA inspections and gap analysis.
What you'll need to succeed
You have at least a university degree in Biotech/Bioprocessing or equivalent of minimal 5-7 year experience in pharmaceutical industry of which 3 years experience in quality. Strong project management skills & proven ability to manage complex projects, the willingness to certify for or possessing Black Belt degree. In addition Passion for Lean and Continuous Improvement and a good command of writing and speaking in Dutch and English • Percentage in service 100%
What you'll get in return
A challenging role within a multinational function which gives you the opportunity to translate global guidelines within de sites in the Netherlands and development as a multi-disciplinary leader.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
Interesse?
Stuur ons dan je CV en motivatie toe door te klikken op onderstaande knop "Reageer op deze vacature".
