Company: Mosaic Regulatory Solutions
Closing Date: 11 Nov 16
Salary (£): Negotiable
To apply for this roe please cal Julie Cooper on 07951 082 482 or send your CV in the strictest confidence to: email@example.com
In order to support the Head of Global Quality Assurance Medicines in maintaining a high-performance QA structure for the entire group, we are currently looking for a
Global Quality Assurance (Senior) Associate Medicines
We are looking for a Quality Assurance Associate who can assist the Head of Global Quality Assurance Medicines in maintaining the integrated Quality Management System for Medicinal products.
You will act according to the Quality Assurance (QA) vision, strategy and standards for the integrated Corporate & Country QA group for Medicinal products.
You will agree Quality Agreements with third-parties (contract manufacturers, logistic service providers, distributors).
You will help with due diligence and integration of new product developments / new product introductions.
You will support technical transfers, qualification and validation work.
You will investigate quality incidents, deviations and complaints, identify and follow-up CAPA’s and improvement plans together with third-parties (contract manufacturers, logistic service providers, distributors).
You will evaluate and follow-up Change Controls together with the Regulatory Affairs team.
You will write Product Quality Reviews.
You will agree stability programs.
You will be part of third-party qualification and regular third-party auditing.
You will lead the internal QA audits.
You will support in the maintenance of the Quality Management System by creating and updating Standard Operating Procedures, Best Practices and Working Instructions.
You will provide QA training to the entire group regarding QA systems and processes and evaluate training effectiveness.
You will maintain databases and documents according to good documentation practices and record retention procedure.
You will assist in the GDP administrative batch control procedure.
You will identify gaps and areas for improvement in QA processes and handling and lead remedial actions and initiatives.
You will keep a going awareness of new and developing regulations related to GDPs and GMPs.
You will act as data administrator in coordinating the complaints (quality defects, adverse events) across the full Pharma business.
You will support QA in data and document collection for regulatory purposes.
You will support QA in ensuring ongoing inspection readiness in your area of responsibilities.
Master degree in pharmaceutical sciences, engineering, biochemistry, chemistry … or equivalent through experience
Being approved as a Qualified Person is an asset (EU release of medicines)
At least 5 years relevant experience in QA in the pharmaceutical industry.
Good knowledge of the relevant European regulations for pharmaceutical products.
Knowledge of FDA regulations for pharmaceutical products is an asset.
Self-starter, capable of working autonomously at corporate level.
Clear communicator, practical and solution orientated.
Enthusiastic and get the job done.
Strong project management skills & team worker in a multicultural environment.
Persistent drive for results in a fast-paced environment, utilizing sound project focus, organizational and problem solving skills.
Regular international travelling (1-2 x/month) is inherent in this role.
You speak and write fluently English. Other languages are an asset.
Our offer :
? A key QA position in a growing organization.
? An appealing international career opportunity in a dynamic, strong growing multinational company environment.
? Apart from a competitive remuneration pack (including pension plan, hospitalisation insurance,…), we offer you excellent personal development and growth opportunities.
? Depending on your level of education, expertise, skills and experience we will offer you a position at Associate or Senior Associate level.
Key skills / Key skill - QA , Quality Assurance Associate , Quality Assurance , GDP , QP , CAPA , Quality Systems , Manager , Belgium , International ,
Mosaic Regulatory Solutions Ltd
|Tel:||0208 305 9733|
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