Quality Assurance GMP Product Compliance Specialist to Chiesi

Chiesi is now recruiting a Quality Assurance (QA) GMP Product Compliance Specialist to the company. The position is based at Campus Solna/Stockholm and we are reaching out to find a new colleague to join a dedicated and highly competent team within the Corporate R&D Quality Assurance department.

Chiesi is an international, research-focused pharmaceutical company that has established a strong heritage in developing innovative pharmaceutical solutions to improve the life of patients with high unmet medical needs. This is an excellent opportunity for you to join a great company with an exciting product pipeline and help bring new innovative medicines to the patients.

We will interview candidates continuously and welcome your application today!

About the position
As a QA GMP Product compliance specialist, you will play a key role in ensuring the compliance and correct application of the Good Manufacturing Practices (e.g. EU and relevant annexes, CFR 21 part 210-211, Part 600 and ISO) within the R&D Department involved and in the Project Teams.

Key responsibility areas include:

• QA GMP Product Compliance Specialist in Project Teams related to Biological Products
• 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
• Review and approval of SAP master data
• CTS 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

Your profile
The right candidate has a PhD, MSc or BSc in relevant scientific discipline (e.g. Biology or Biotechnology, Chemistry and Pharmaceutical Technology, Pharmacy). You have multiple years of experience within Pharmaceutical/Biopharmaceutical Quality Assurance, Quality Control or production.

Further experiences sought for:
• Knowledge of the EU-GMP, CFR 21 part 210-211 and 600, ICH and ISO regulations in the field of pharmaceutical development
• Knowledge of the process of drug development
• Knowledge of drug product and/or drug manufacturing processes
• Knowledge of analytical/bioanalytical techniques

To be successful in this role you have strong organizational and team working skills and enjoy effectively collaborating with dedicated and friendly colleagues in a multi-disciplinary environment. You are result-oriented and have excellent communication skills combined with assertiveness and decision making ability. Furthermore, you are analytical and able to handle multiple tasks independently and manage priorities in a timely manner. Fluent English both speaking and in writing is required.
Availability to travel is required for this position.

About the organisation
A GLOBAL FAMILY DEDICATED TO PEOPLE AND PATIENTS
In Chiesi our approach as a Benefit Corporation is a way of being as well as a way of thinking. We redefine the way to do our business, to create a positive impact on people, environment and our global Chiesi Community, acting as a force for good.
We are passionate and committed to improving and raising the quality of human life and making meaningful contributions that will have a positive long lasting impact. Our entrepreneurial thinking, our sustainable and innovative ideas, transformative solutions and our personal chemistry are the key elements that bonds us and make us grow as one cohesive global Chiesi family.

EVERYONE OF US IS DIFFERENT, EVERYONE OF US IS CHIESI
For information about Chiesi, please visit www.chiesi.com

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