Interim Quality Assurance Pharmacist (QAP)

Interim Quality Assurance Pharmacist (QAP)

Interim management is an effective managerial solution for companies of all sizes to deal with an unprecedented situation, a managerial emergency or to accelerate their transformation.

MANAGERIM, expert in interim management, provides you with interim managers Pharmacists & experts in quality management in the pharmaceutical and cosmetic industry everywhere in France, Europe or further (Africa, Asia, Middle East...).

Our community of interim managers in quality management includes top and middle managers in Quality in the Health industries (Pharmaceuticals, Cosmetics, Medical Devices, Biotechnology...): Quality Director, Pharmacist Quality Manager, Quality Assurance Manager, Quality Control Manager, Quality Project Managers... with:

• solid experience in the pharmaceutical sector in quality system management,
• Pharmacist education with additional training and skills in Industrial Quality Assurance or Control
• a good knowledge of pharmaceutical regulations (e.g.: AMM files...) and of numerous reference systems (GMP, BPD/GDP...), methodologies or best practices
• experience in internal and external audits
• a capacity for analysis and synthesis and a strong sense of responsibility
• a taste for teamwork and good communication skills
• skills in conducting continuous improvement processes...

Our interim managers are men and women selected after a rigorous and demanding process, as much for their expertise as for their interpersonal skills.

The missions of an interim quality assurance pharmacist

The Interim Quality Manager Pharmacist is the unique referent of a site or a pharmaceutical company in terms of quality of products delivered to the public. He/she is ultimately responsible for compliance with health and safety rules. He/she guarantees the quality and conformity of finished products.

He/she develops and implements quality procedures by ensuring that production complies with customer specifications and that the various departments are consistent.

Assignments may include various responsibilities:

• Ensure the pharmaceutical responsibility of a site and guarantee the compliance of the quality system with GMP and other applicable standards, legal requirements and company guidelines
• Managing the Quality teams under your responsibility (Quality Managers, Quality Assurance, Quality Control, Laboratory, etc.): leading, coordinating, supporting the development of skills, etc.
• Ensure the proper functioning of the Quality Assurance and Quality Control departments
• Carry out or supervise the release and final certification of pharmaceutical drug batches for customers
• Manage and supervise the management of deviations, OOS, OOT, CAPAs, complaints and changes on site
• Manage the preparation, conduct and follow-up of health authorities and subcontractors inspections and internal audits
• Strengthen the Quality Management System and ensure its implementation and maintenance
• Initiate and manage projects for continuous improvement of the site's quality system

Why mobilize an interim quality manager from our interim management firm MANAGERIM?

Our interim Quality Managers have previous successful experience in quality management in the health industries (Pharmaceuticals, Cosmetics, Medical Devices, Biotechnology...):

• in France and abroad in pharmaceutical and CDMO laboratories of different sizes in mono and multi-site environments,
• of different types (liquid, solid or dry forms, injectable/sterile, implants...)
• in different contexts (site opening, transformation, restructuring, launch of new activities, crisis management...)

They know how to adapt rapidly and be immediately operational.

Our transition managers Pharmacist Quality Assurance Officers intervene on high added value missions in various situations:

• Temporary replacement of a manager at short notice: Quality Director, Pharmacist Quality Manager, Regulatory Compliance Manager, Quality Assurance Manager, Quality Control Manager, Quality Project Manager...
• Operational reinforcement of a team in a period of overload or tension
• Flash 360° audit of the organization and of the Quality Management System (QMS)
• Structuring, redesigning or strengthening the QMS and processes
• Organize and monitor all pharmaceutical operations of a site
• Ensure regulatory compliance
• Guaranteeing the quality of products released within the framework of current regulations and customer specifications, while respecting the schedule and cost of production
• Manage quality improvement initiatives
• Identify cost optimization levers
• Plan, control and follow up on quality audits and Health Authority Inspections
• Develop the Quality culture on a site
• Project management (reorganization, remobilization, specific certification or accreditation procedures, lean management procedures, etc.)
• Strengthen cooperation with the production, supply chain and technical teams
• Ensure the interface with customers and administrative authorities
• Crisis management
• Change management

Throughout their assignments, our interim managers are supported by one of our partners, who guarantees the quality of the assignment and the methodology developed by MANAGERIM.