Download Site Compliance Network Member

Site Compliance Network Member
For one of his Pharma customers in Puurs with one of the largest production units in
Europe, CMAST is looking a Site Compliance Network Member who will be working as a
consultant in one of the indicated specifications.
CMAST provides Consultancy, Project Management and Business Supporting IT solutions for Life
Science Companies and more specific in the field of Strategic Collaborations, R&D, Production and
Supply Chain.
Job description:
____
Registration
The production processes and analytical methods of the drug products are described in the
registration dossiers of the different markets. The SCNM is responsible to ensure regulatory CMC
compliance of the practice of the site versus the content of the registration dossiers. This is achieved
by participating in the following processes:
- Renewals: maintain and support the existing registrations in the markets
- Regulatory change control process:
- Determine regulatory impact for proposed process changes
- Compile the required supporting data package for the regulatory submission
(variation)
- Respond to Board of Health queries
- Respond to compliance-related questions from Boards of Health
- Performing regular compliance checks of the registration dossiers of the different markets
versus the site practice to ensure that the site practice is still in line with the dossiers
CMAST bvba Georges Van Dammeplein 57 B9140 Temse +32 3 334 35 00 [email protected] www.cmast.be
To this end, the SCNM has intensive consultations with partners within and outside the site. The
external contacts with the Boards of Health of the markets mainly go through Pfizer GCMC (Global
Chemistry, Manufacturing & Controls), with whom the SCNM maintains a close partnership. An
important role of the SCNM is to form the bridge between the site and GCMC (~Boards of Health);
on one hand the SCNM informs site colleagues on regulatory requirements, timelines, etc. and on
the other hand the SCNM guards the interests of the site in external discussions.
Validation
The SCNM is the independent quality authority for product-related validations and in that way
guards the quality of those validations and therefore the product quality.
The validation domains in scope are:
- Process validation
- Method validation
- Filter validation
- Component qualification
- Raw material evaluation
Implementation
The SCNM assist in coordinating the implementation of changes with regulatory impact in the site.
To this end, he/she will follow up on the submissions and approvals in the different markets, and will
provide this feedback to the site colleagues.
In addition, the SCNM is responsible for the content of the test plans (master data) in the LIMS
system. This way, the SCNM ensures that the testing performed on the drug products is in
compliance with the registration dossiers of the different markets.
Ap p l i c a n t p r o f i l e :
____

Degree: University

Formal education: Scientific discipline (e.g. industrial pharmacist, biomedical sciences, bioengineer,…)

Experience required: Minimum 2 years experience in the pharmaceutical sector (or equivalent by
acquiring a PhD), with experience or interest in documentation of manufacturing methods or test
methods.

Specific training and skills:
CMAST bvba Georges Van Dammeplein 57 B9140 Temse +32 3 334 35 00 [email protected] www.cmast.be
o
Excellent oral and written communication (Dutch / English)
o
Excellent social skills
o
Scientific knowledge and skills
Job Location:
____
Puurs, Belgium
We offer:
____
A competitive salary package according to applicant’s experience.
CMAST bvba Georges Van Dammeplein 57 B9140 Temse +32 3 334 35 00 [email protected] www.cmast.be