Senior Quality Assurance Specialist for Corporate Operations

1 settimana fa

Parma, Emilia-Romagna, Italia Chiesi Group A tempo pieno
Who we are looking for Main Responsibilities

Oversee the management of products and projects within the respiratory sector, focusing on both qualitative and analytical assessments.
- Collaborate with various departments locally and at the corporate level, engaging with R&D, regulatory bodies, and external consultants.
- Assist in the establishment of guidelines for system and process validation activities, ensuring compliance with National and International GMP standards.
- Supervise validation efforts at Chiesi facilities by analyzing data and determining corrective measures with local teams.
- Contribute to the creation and preparation of validation documentation for Corporate products and/or new lines or departments at Chiesi production facilities.
- Manage change control and deviations related to Corporate products and processes.
- Provide assistance, as needed, in strategic planning activities within Industrial Management:
o Conduct scenario analyses;
o Perform business continuity risk assessments;
o Define insourcing/outsourcing strategies in the industrial sector;
- Aid in drafting Technical Agreements when collaborating with suppliers of materials and services.
- Support the development of industrialization programs for new products or the implementation of new production processes for existing market products.

Experience Required

A minimum of 6-8 years of experience in Quality Assurance within the pharmaceutical sector.

Education

Degree in Chemistry, Industrial Chemistry, CTF, Biotechnology, Biology, or a related field.

Languages

Proficient in English;
- Knowledge of French is considered an advantage.

Technical Skills

Strong understanding of international pharmaceutical regulations (particularly CFR tit21 and European directives) and global regulatory references (FDA, EMEA, ICH) related to the production, control, and distribution of pharmaceuticals, as well as familiarity with major international pharmacopoeias and GMP (EU, USA, PICs, WHO).
- Knowledge of Total Quality Management principles and standards;
- Familiarity with management information systems (ERP);
- Understanding of suppliers and subcontractors within the Italian and potentially European markets, especially concerning manufacturers of active ingredients and excipients for pharmaceutical applications;
- Proficient in Risk Management, Auditing, and Training methodologies.

Soft Skills
  • Proactive approach
  • Adaptability and flexibility
  • Strong communication abilities
  • Commitment to quality

What we offer

You will be part of a dynamic, rapidly growing, and supportive environment.
At Chiesi, we firmly believe that our employees are our greatest asset, which is why we invest in ongoing training, learning, and development. We are dedicated to continuously addressing and fulfilling development needs, with a strong emphasis on the quality of our work environment and collective well-being.
We want our employees to feel happy at work every day, and we recognize the importance of achieving the right work-life balance to perform at their best. Consequently, we provide a flexible working approach, remote work options, assistance with relocation, tax support for international colleagues, and a variety of other employee-focused services.

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