Quality Specialist

il y a 4 jours

Paris, France Pharmalex Temps plein

**We are growing, grow with us**
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

**Quality Specialist**
- This position requires weekly office attendance, hence we'll consider applicants from Paris and surroundings **_

This role demands an ability to communicate effectively across the team and with clients, to act as a Pharma Blue ambassador, displaying clear communication skills and comprehensive understanding of our organization.

**Your Job**
- Under (senior) management supervision, providing a full range of support services within personal area of expertise (guidance and /or operational support, writing and training)
- Ensuring high quality and on time delivery of support services to internal and external clients, maintaining client satisfaction
- Supporting preparation of regulatory strategic advice for the life cycle management of pharmaceutical products for France
- Supporting/preparating interactions with Health Authorities

Quality Assurance Exploitant:

- Supporting the local process for “exploitant” authorization and opening
- Assisting to self-inspection or authorities inspection
- Preparing/participating to quality reviews and quality management reviews
- Preparing deviations, corrective / preventive actions, change controls and quality action plans
- Contributing to the management of the quality system documentation, including initial training and continuous training according to the current standards (Public Health Code, GMP, GDP, Promotional Information Charter )
- Contributing to the update of internal trainings related to quality and regulatory topics
- Monitoring quality indicators and improvement plans
- Preparing third-parties qualification assessments
- Contributing to the follow-up of third parties providers

Quality Assurance on Projects:

- Supporting the preparation of client audits

**Your Profile**
- At least 2 years initial quality experience gained through internship/regular employment in pharmaceutical/biotechnical companies and/or regulatory authorities
- Ideally a Graduate with a Life Sciences degree or equivalent qualification as a minimum
- Native French and full professional proficiency in English are musts

For further information please don’t hesitate to contact us.

Agencies only by prior agreement for the specific job opportunity.

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