col-wideJob Description:
The Context
A renowned and historic production company in the pharmaceutical sector, known for its diversified product range and commitment to the highest international quality standards, is currently seeking a Quality Director & QP. This pivotal role will help navigate the company through a significant transition period.
The Role
We are looking for an exceptional candidate to take on the dual responsibilities of Qualified Person and Quality Director (QC and QA), overseeing a substantial team of direct and indirect reports.Key responsibilities include:
Regulatory Compliance:Ensuring full adherence to legal requirements for the Qualified Person in interactions with local and European Authorities.
Batch Release:Guaranteeing that each batch is analyzed and released for market distribution in compliance with GMP and relevant legal standards in Italy and destination countries. Ensuring the production facility maintains its manufacturing authorization and operates within regulatory guidelines.
Development Support:Deciding on the introduction of new products and technologies, ensuring regulatory compliance, securing necessary authorizations, and adhering to legal provisions.
Quality Control:Overseeing quality controls, chemical, and physicochemical analyses of finished products, raw materials, and packaging, as well as microbiological analyses in compliance with GMP standards.Supporting all validation activities.
Stability Studies:Managing stability studies and documentation according to current regulations and ICH guidelines.
Quality System Management:Leading the Quality System area with a team dedicated to the documentation and procedural aspects of Quality.
The RequirementsEducational Background:Degree in pharmaceutical chemistry and technology, pharmacy, chemistry, industrial chemistry, biological sciences, medicine and surgery, or veterinary medicine.
Professional Credentials:Licensed to practice and registered with the professional board.
Language Skills:Advanced English proficiency (minimum level B2).
Regulatory Knowledge:Deep understanding of GMP and industry regulations.
Process Expertise:Extensive knowledge of internal and general production processes.
Quality Systems:Thorough familiarity with the company's quality system and current procedures.
Technical Skills:Proficiency in office and specialized departmental software.
Safety Standards:Knowledge of laboratory safety regulations.
Leadership and Collaboration:Strong decision-making, leadership, and team development skills.
Problem Solving:Effective problem-solving abilities.
Negotiation Skills:Proven negotiation capabilities.
Strategic Vision:Ability to plan and maintain a comprehensive vision.
Confidentiality:Commitment to maintaining confidentiality.
This is a unique opportunity to play a critical role in a prestigious company during a key phase of its growth and transformation. If you possess the expertise and drive to excel in this role, we would love to hear from you.
