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Qualified Person

  • Location: England
  • Salary: Negotiable per hour
  • Job Type:Contract

Posted 24 days ago

Qualified Person UK

RESPONSIBILITIES :

· This is a key role within the quality organization which has direct responsibility for product release. A thorough previous experience in the industry is required to understand best practices.

· Responsible for oversight of the Quality Operation functions by providing direction, overseeing the Quality Assurance organization on the shopfloor. You will supervise, manage and develop a multidisciplinary team. You will have 3-4 direct reports.

· Coordination between the QA Operation team within and outside of the Q organization to ensure efficient working environment and communication of quality related topics (communication with ANSM, Sanofi, Regeneron..).

· Drive deviation reduction program.

· Installing 24/7 Quality on the shopfloor program.

· Be the primary contact for ANSM.

ATTRACTIVENESS OF THE POSITION

This role is critical to the plant operations and will have a direct managerial impact on the operations in production.

The ability to build close working relationships with other teams in the site and the ability to interact within the other stakeholders across the supply chain is essential.

Opportunity to develop people , improve processes.

PROFILE

Education/experiences

· 5 - 10 years of experience within the Pharmaceutical Industry within the QA function having oversight and interaction with production operations and support functions such as engineering, maintenance, validation…

· Pharmacist and previous experiences as QP,

· Regulatory inspection experiences,

· Excellent knowledge of GMP and regulatory expectations in US and EU cGMPs

Competencies

· Excellent people leadership and change leadership skills,

· Proven process understanding (pharma, GMP, investigation, release),

· Direct experience with Fill & Finish PFS,

· Experience in continuous improvement process and ability to identify opportunities for continued improvements and improve performances within your team.

· Excellent communication skills, good presentation skills

· Fluency in French and English in speaking, understanding and writing,

· Ability to influence key decision makers,

· Well organized, autonomous, rigorous, pragmatic,

· Able to define and support strategy

If you are interested in this role, please send your CV to peterjefferys@hydrogengroup.com

If you know anyone who may be interested I am offering £500 referral fee for any successful candidate!

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