Global R&D QA, Senior GMP Product Compliance Specialist
Parma, IT
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with 90 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.
We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.
In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
Chiesi Research & Development
Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).
Who we are looking for
Purpose
Guarantee the compliance with EU and US regulations related to the application of the Good Manufacturing Practices for biological products for clinical trials.
Main Responsibilities
- QA GMP reference in Project Teams related to Biological Products for clinical trials
- Review of Master Batch Record related to biotechnological Drug Substance, Drug Product and Advanced Therapy medicinal Products
- Management of change, OOS, deviation, Temperature excursions
- Review of GMP protocol and report (Technology transfer, Process validation, etc.)
- Clinical Trials Supplies complaint management
- Quality Agreement review for the relevant sections in relation to the projects assigned
Drafting, revision and harmonization of Standard Operating Procedure
Training execution on the Standard Operating Procedure
QA site compliance (Sweden laboratories)
Experience Required
Experience in Quality Assurance, Quality Control or production in Biotech/Biopharmaceutical companies of at least 5 years.
Education
Degree in Biology or Biotechnology, Chemistry and Pharmaceutical Technology, Pharmacy.
Languages
Proficient in spoken and written English.
Technical Skills
- Knowledge of the EU-GMP, CFR 21 part 210-211 and 600, ICH in the field of pharmaceutical development
- Knowledge of the process of drug development
- Knowledge of drug product manufacturing processes, in particular sterile/aseptic/lyophilization processes applied to biological products
- Knowledge of drug substance manufacturing processes, in particular recombinant proteins, monoclonal antibodies
- Knowledge of analytical/bioanalytical technique
- Knowledge of ERP and EDMS
- Knowledge of training technique
Soft Skills
- Planning and organization skills
- Team working
- Decision making ability
- Independence in judgment and objectiveness
Location
Parma, IT. Availability is requested to spend 25% of the time at the R&D site in Sweden.
What we offer
You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
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