Location: Braine-l'Alleud
Job #26442

External Operations Quality Partner
Brabant Wallon – Contracting
What are your responsibilities?

Batch record review and administrative support (e.g., updating CoC, handling deviations, complaints, temperature excursions).
Provide timely and efficient GMP/GDP IMP Release function to all relevant internal project activities related to the development of the pipeline projects
Support compliance with all relevant and appropriate regulations and guidelines, such as those relating to GMP/GDP, health and safety, etc..
Support the systems and processes in place for the appropriate documentation of internal development activities and to maintain them in a manner compliant with regulatory and corporate requirements.
Ensure the Clinical Supply Quality activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house).
Proactively support the activities of Clinical supply for relevant manufacturing quality systems (deviation close out / Change management / complaints / quality improvement).
Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions.
Provide support in the evaluation of Temperature excursions for IMP.
Management of Quality Complaints of IMP.
Ensure active participation in the selection, evaluation, approval and maintenance of Vendors for IMP activities, including leadership or support to conduct appropriate audits.
Oversight of Distribution activities (deviations, Business Review Meetings, assessments, etc…)
Ensure CMO (packaging and distribution vendors) quality documentation is accurate and up-to-date, by editing and reviewing quality agreements
Contribute the preparation of audits (internal/external, regulatory inspections)
Lead internal audits / Self-Inspections

Who are you?

5 years’ experience in QA/compliance experience in pharmaceutical regulated environment
Good knowledge of cGMP and relevant regulatory requirements (e.g US, European, Japanese)
Strong experience in batch review.
Quality mindset with a pragmatic and proactive approach.
Fluent in English is a must and French is a nice to have.
Experience working with CMOs and vendors.
Familiarity with GMP and GDP standards.
Experience with quality systems (deviation management, complaints, change control)
Familiarity with clinical packaging environments (vs. commercial) is a plus
Certified auditor status is a plus.

Our offer?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We invite you to apply!

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External Operations Quality Partner Brabant Wallon – Contracting What are your responsibilities?

Batch record review and administrative support (e.g., updating CoC, handling deviations, complaints, temperature excursions).

Provide timely and efficient GMP/GDP IMP Release function to all relevant internal project activities related to the development of the pipeline projects

Support compliance with all relevant and appropriate regulations and guidelines, such as those relating to GMP/GDP, health and safety, etc..

Support the systems and processes in place for the appropriate documentation of internal development activities and to maintain them in a manner compliant with regulatory and corporate requirements.

Ensure the Clinical Supply Quality activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house).

Proactively support the activities of Clinical supply for relevant manufacturing quality systems (deviation close out / Change management / complaints / quality improvement).

Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions.

Provide support in the evaluation of Temperature excursions for IMP.

Management of Quality Complaints of IMP.

Ensure active participation in the selection, evaluation, approval and maintenance of Vendors for IMP activities, including leadership or support to conduct appropriate audits.

Oversight of Distribution activities (deviations, Business Review Meetings, assessments, etc…)

Ensure CMO (packaging and distribution vendors) quality documentation is accurate and up-to-date, by editing and reviewing quality agreements

Contribute the preparation of audits (internal/external, regulatory inspections)

Lead internal audits / Self-Inspections

Who are you?

5 years’ experience in QA/compliance experience in pharmaceutical regulated environment

Good knowledge of cGMP and relevant regulatory requirements (e.g US, European, Japanese)

Strong experience in batch review.

Quality mindset with a pragmatic and proactive approach.

Fluent in English is a must and French is a nice to have.

Experience working with CMOs and vendors.

Familiarity with GMP and GDP standards.

Experience with quality systems (deviation management, complaints, change control)

Familiarity with clinical packaging environments (vs. commercial) is a plus

Certified auditor status is a plus.

Our offer? Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We invite you to apply!

First Name:

Last Name:

Email Address:

Phone Number:

Upload CV File:

People looking for jobs should not put anything here.

External Operations Quality Partner
Brabant Wallon – Contracting
What are your responsibilities?

Our offer?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We invite you to apply!