Why work for Scalian?
We are an international engineering consultancy company with expertise in Digital Systems (software development, embedded systems), Operations Performance (Project Management, Quality Management) and Digital Transformation. We have offices worldwide (France, Belgium, Spain, UK, Germany, US & Canada) and offer international mobility opportunities.
Purpose of the role
In the context of a fast track project aiming to produce a new adjuvant in the building by the
end of 2020, provide QA support and oversight to validation activities according to GSK
This is a multidisciplinary project, MPU working with Belgium engineering & validation
teams in order to adapt the productions areas & equipement to our needs, and to
transpose a production process.
The diagnosis phase of the equipment used for the project will be done at the beginning of
June, IOQ & PQs are planned from august until end of November.
We expect the consultant to be the main contact for QA validation activities during the
whole project, and to ensure the follow up of the project with QA val/TS team (to
communicate the strategy, brainstorm in case of difficulties and escalate issues).
Provide compliance expertise in validation
Ensure QA oversight in validation activities (IQOQ / PQ / PV…)
Review/Approve the validation documentation regarding the GMP requirements
and the GSK Vaccines procedures
Ensure that production practices are aligned with the validation conclusion
Attend all project meetings as QA validation representative
Ensure timely escalation to management of critical issues during validation
Contribute to the deviation process providing QA oversight and approving deviation
for deviations related to validation activities and/or impact of manufacturing
deviations to validation activities
Pro-actively identify potential quality and compliance risks and manage these risks
through the risk register and quality plan process
Work in autonomy with GSK supervision/coaching
To define the validation strategies through the change control process
To write and implement some validation documentation (Validation Plan, Validation
Summary Report, Risk Assessment, Gap Analysis, Periodic review ….)
To ensure the correct application of the validation quality systems in the field and to
define improvement plan as required
To support the production, QA and technical service teams in the implementation of
the validation activities.
Required Experience & Knowledge:
University degree (Biotechnology, Agronomy, Chemistry or Pharmacy)
Former relevant industrial experience related to the requested seniority in
Validation and QA in a biopharmaceutical industry.
Knowledge of GMP / CFR / Eudralex
Knowledge of different regulations and standards related to validation activites
For this fast track project, we expect a well qualified contingent worker
for QA validation activities & having a good overview of GSK ways of working
Good interpersonal skills
Good oral and written communication skills in French & English
Problem solving and achievement oriented
Good team player in order to succeed in each validation project and routine
To be able to use a risk-based approach for problem solving and prioritization of
Knowledge of GSK tools (e.g. SAP, documentum) is an asset.