quality assurance gmp (good manufacturing practice) specialist - 10365.

The QA/QP:

• Ensures that operations in relation to imported or manufactured raw materials and bulk pharmaceutical products comply with national and/or international regulations and guidelines (cGMP) as well as the company's quality policies.

• Ensures that products comply with the relevant marketing dossiers.

• Takes decisions on the release, rejection or re-working of these products.

• Proactively assists operations in identifying, developing and implementing quality and operational excellence improvements in response to business, technical and regulatory requirements.

As a QA/QP, your main responsibilities will include:

• Release and certification of the above mentioned product batches, management of legal samples.

• Management of quality deviations, investigations, CAPAs, market/customer complaints, recalls, temporary and permanent change controls.

• Drafting, review and approval of Product Quality Reviews.

• Drafting, review and approval of procedures related to the field of activity.

• Follow-up and QA support to projects defined by the QA management, and more specifically in relation to the release and production activities of dry forms.

• Carrying out internal audits, participating in customer audits and inspections in relation to the field of activity.

For this assignment we are looking for the following qualifications and skills:

• Degree in Industrial Pharmacy with Qualified Person (QP) number. 

• Experience in the pharmaceutical GMP environment in a similar position, and/or experience in Quality Assurance, Production or Quality Control

• Knowledge of international regulations related to GMP activities. 

• Very good knowledge of French and English (spoken and written). 

Soft skills : 

• Able to take decisions based on facts and to take responsibility for them.

• Sense of discretion and ethics.

• Highly developed team spirit, excellent interpersonal skills, including oral and written communication.

• Resistant to stress.

• Ability to solve problems and provide constructive and innovative solutions.

Consultancy

We offer an attractive salary with extra-legal advantages: 

• Group insurance

• Hospitalisation insurance

• Meal vouchers of 7 euros gross per working day

• Reimbursement km or company car 

• Monthly allowance (80 euros net per month)

• A 13th month

• Training

• Etc.

A rate as a freelancer is also possible.