PDS QA Process & Cleaning Validation Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you will discover a meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day, enabling our customers to make the world healthier, cleaner and safer!

You will have to opportunity to join the Quality team in our Pharmaceutical Development Service Unit, an innovative facility where we support clients in manufacturing clinical trial batches and small-scale commercial batches of sterile injectable products.

Working in a dynamic and very exciting environment, a strong GMP background as well as effective communication skills will be key. You will take part in the design, validation and regulatory approval of life-saving and innovative drugs, where your contribution will make the difference

Responsibilities:

• Work closely with cross-functional teams for the process design stage of new products and take part in the definition of process/cleaning validation strategy
• Review all validation documents to assure the production of high-quality pharmaceutical products that meet strict regulatory requirements
• Participate in the investigation related to validation activities, supporting in the impact assessment evaluation and in the implementation of corrective and preventive actions
• Support the regulatory team during the submission phase of new commercial products
• Review change control related to registration and PPQ batches
• Provide quality support for new product transfer and implementation of new processes. Find opportunities for process improvements and lead initiatives to improve the validation process. Assure that accurate cross contamination control strategies are in place to avoid contamination and mix up event

Requirements:

We are looking for an ambitious individual with:

• Degree in Medicinal Chemistry and Pharmaceutical Technologies/Pharmacy/Chemistry/Chemical Engineering/Biotechnology or related scientific subject areas
• Experience in development and manufacturing of sterile products and, if possible, with experience in process and cleaning validation topics;
• Strong knowledge of regulatory requirements and industry standards;
• Proficient English with advanced written and oral communication skills;
• Proficiency in Microsoft Office software; knowledge of statistical tool and Trackwise software is a plus;
• Good problem-solving abilities, excellent communication and team working skills; ability to multi-task and prioritize to meet important goals. Critical spirit and Attention to details

What We Offer

At Thermo Fisher Scientific Inc., we believe in investing in our people. We offer:

• A collaborative and inclusive work environment.
• The opportunity to work with brand-new technology and contribute to impactful projects.

Join us in Monza and be part of a company that is determined to make a difference. Your work will help ensure we continue to deliver innovative solutions that improve the lives of people around the world.

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