Senior Associate QA (GMP)
Titel: 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
The primary purpose of the position is completing the Receipt Approval process for incoming Investigational Medicinal Products,-review and approve completed expiration date re-labeling and labeling MP’s ensuring all procedural requirements are met.
You are responsible for the review and approval of temperature excursions at clinical sites and during transport-compliance review and approval of clinical label artwork,-assists in resolution of compliance and quality issues related to the transport of clinical products. In addition you will be responsible for reviewing and approving class 1 non-conformances ensuring all procedural requirements are met, owning and generating of operational SOP’s and Work Instructions, review of SOP’s and ensuring that Corporate, Site and Regulatory requirements are met. You will participate in ABR internal audits as needed, initiate and own non-conformances as required, assist in the development and delivery of GMP training activities and various investigations as needed (including complaints).
You will act as Quality first point of contact in providing guidance and support to Clinical Supply Chain Management (CSCM), Production and Warehouse/ Distribution staff in regards to compliance with Quality policies and procedures, develop and maintain effective, partnering relationships with company affiliates.
Participation in global Quality initiatives ensuring ABR QA input is provided and assisting in ABR implementation activities and ABR projects and improvement efforts will also be a part of this role.
What you'll need to succeed
Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience, typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review, investigations and analytical testing, 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 and fluent in English language.
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
The primary purpose of the position is completing the Receipt Approval process for incoming Investigational Medicinal Products,-review and approve completed expiration date re-labeling and labeling MP’s ensuring all procedural requirements are met.
You are responsible for the review and approval of temperature excursions at clinical sites and during transport-compliance review and approval of clinical label artwork,-assists in resolution of compliance and quality issues related to the transport of clinical products. In addition you will be responsible for reviewing and approving class 1 non-conformances ensuring all procedural requirements are met, owning and generating of operational SOP’s and Work Instructions, review of SOP’s and ensuring that Corporate, Site and Regulatory requirements are met. You will participate in ABR internal audits as needed, initiate and own non-conformances as required, assist in the development and delivery of GMP training activities and various investigations as needed (including complaints).
You will act as Quality first point of contact in providing guidance and support to Clinical Supply Chain Management (CSCM), Production and Warehouse/ Distribution staff in regards to compliance with Quality policies and procedures, develop and maintain effective, partnering relationships with company affiliates.
Participation in global Quality initiatives ensuring ABR QA input is provided and assisting in ABR implementation activities and ABR projects and improvement efforts will also be a part of this role.
What you'll need to succeed
Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience, typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review, investigations and analytical testing, 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 and fluent in English language.
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".
