Sr. Specialist Commercial Manufacturing QA

Job content

Summary

The Senior Specialist, Commercial Manufacturing QA is responsible for executing Quality operations tasks related to commercial manufacturing and testing activities performed at CMOs for the assigned products (Drug substance and Drug Product).

Duties And Responsabilities

• Day-to day QA oversight of assigned commercial CMOs in charge of Drug Substances and Drug Products manufacturing,
• Creates, approves and maintains Product monographs,
• Performs batch records review and disposition of batches,
• Maintains and controls the product batch records filling and archiving,
• Reviews and approves internal and external deviations, OOS, OOT and related investigations,
• Ensures implementation of internal and external change controls,
• Ensures implementation of internal and external CAPAs,
• Quality review of stability data for commercial products,
• Coordinates the collection of Annual Product Quality Reviews data and issues Incyte APQR for the assigned product(s),
• Maintains Quality and Technical Agreements with assigned CMOs,
• Performs external and internal GMP audits according to Incyte audit program,
• Contributes to the maintenance of Incyte Quality Management System,
• Supports the regulatory submissions and follow-ups,
• Ensures inspection readiness at assigned Commercial CMOs,
• Interprets GMP, general regulatory requirements and Quality systems regulations in the area of manufacturing and ensures implementation as applicable,
• Performs all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements,
• Stays current with the applicable regulations and promotes Quality across the Incyte organization,
• Cooperates with the Commercial Supply Chain, RA-CMC, Analytical and Manufacturing Operations and Regulatory Affairs functions in matters relating to Commercial Products.
  

Requirements

• Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering);
• Firsthand experience of min 5 years in Quality Operations and/or Quality Control for pharmaceuticals;
• Experience in Contractors Quality oversight;
• Thorough knowledge in cGMP and international regulatory requirements (US, EU, JP);
• Experience in small molecules in various pharmaceutical forms including topical;
• Demonstrated ability to write technical documents such as APQR;
• Auditing experience is preferred;
• Strong Interpersonal skills, team-oriented way of working;
• Strong verbal and written communication skills with well-structured communication and presentation ability in the company language;
• Ability to manage multiple on-going projects;
• Results focused which may require negotiating skills, empathy, diplomacy, common sense
• English fluency written and spoken (the company language);
• Travel, up to 20%
  

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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