NL CW Senior Associate QA (GMP)
Titel: NL CW Senior Associate QA (GMP)
Werkgever: Hays
Plaats: Provincie Noord-Brabant
Provincie:
Locatie:
Provincie Noord-Brabant /
Omschrijving:
Your new company
This company is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Your new role
You will provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions. You will act as a first point of contact in case of production queries (quality related) during packaging and labelling operations. Reviewing and approving batch production record data entries before production activities take place . You will perform finished product checks during (commercial) production runs, and compile and review batch records for lots assembled, packaged and labelled at ABR and contract manufacturers in preparation for disposition by QP. Last the review and approve class I Non Conformances will be one of your responsibilities.
What you'll need to succeed
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent.
Minimum Requirements
MBO or Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience. 3 Years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.
Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases. Manufacturing and/or Quality analytical processes and operations. You are fluent in English language. The systems you will work with are TrackWise (NC/CAPA), SAP and MS Office (Word, Excel)
IMPORTANT: working in early, late and night shifts (night once per 5 weeks)
Skills
You are analytical, a teamplayer, can work independently, have a hands-on and result driven mentality. You have strong communication skills, are excellent in English and have a quality mindset
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
This company is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Your new role
You will provide daily guidance and support to Production staff in regards to compliance with Standard Operating Procedures and Work Instructions. You will act as a first point of contact in case of production queries (quality related) during packaging and labelling operations. Reviewing and approving batch production record data entries before production activities take place . You will perform finished product checks during (commercial) production runs, and compile and review batch records for lots assembled, packaged and labelled at ABR and contract manufacturers in preparation for disposition by QP. Last the review and approve class I Non Conformances will be one of your responsibilities.
What you'll need to succeed
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent.
Minimum Requirements
MBO or Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience. 3 Years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.
Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases. Manufacturing and/or Quality analytical processes and operations. You are fluent in English language. The systems you will work with are TrackWise (NC/CAPA), SAP and MS Office (Word, Excel)
IMPORTANT: working in early, late and night shifts (night once per 5 weeks)
Skills
You are analytical, a teamplayer, can work independently, have a hands-on and result driven mentality. You have strong communication skills, are excellent in English and have a quality mindset
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".
