Technology Transfer Specialist (QC) - Corporate (Italy or UK)
RecordatiAbout the role
The contex/Company description
Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), with a total staff of more than 4,300, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations in Europe, Russia and the other C.I.S. countries, Ukraine, Turkey, North Africa, the United States of America, Canada, Mexico, some South American countries, Japan and Australia. An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in several therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati is a partner of choice for new product licenses for its territories. Recordati is committed to the research and development of new specialties with a focus on treatments for rare diseases.
Your contribution/mission
You will be part of a fast moving environment and will report directly to the Group Technology Transfer Manager. You will be accountable for coordinating technical transfer projects (drug products, substances and analytical methods) between the sending and receiving sites to ensure design and transfer of robust manufacturing processes.
As Tech Transfer PM you will lead, track, follow up and monitor all the transfer activities to ensure alignment with the project scope; always in contact with all the group key function: procurement, finance, supply chain, regulatory, quality.
As part you your mission you will also prepare and present projects reports and the needed documentation such as request for proposal, technology transfer plan/scope, project timeline, GAP assessment in addition to process validation protocol, manufacturing batch records, analytical protocols/report.
Your profile
You have a Bachelor’s degree in a scientific discipline (chemistry, pharmacy, pharmaceutical science, biology, industrial engineering) at least 5 years experience in Tech transfer project management/quality control/ analytical development- quality control experience is mandatory.
You have excellent communication skills both verbal and written and you are fluent in English; you are able to build critical relationships and manage negotiations.
Thanks to your ability to work indipendently and with a “hands on” approach, you feel comfortable in writing, reviewing and approving processes, analytical protocols, reports, regulatory justifications, SOPs, Specifications and records (Deviations/Non-conformities management, Change Control and knowledge of CAPA processes will be considered a plus).
Additional information
Location: European Country
Direct Manager: Group Technology Transfer Manager
Travel required: according to the projects
“At Recordati, we believe in equal opportunities and we guarantee that everyone can achieve their potential. We see diversity as a value and will not tolerate any discrimination based on ethnicity, nationality, gender, sexual orientation, disability, age, political or religious belief, or any other personal characteristics. At Recordati, we work hard to create a safe and inclusive work environment, where we all have our rights to physical and psychological integrity respected on a daily basis, as well as our right to freedom of opinion and association. We recognise that we each have a role to play in the success of our business and we implement staff development policies through which everyone’s contribution and achievements can be appropriately rewarded.”
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