QA Specialist, QA DS Manufacturing Operations

QA Drug Substance Manufacturing is a team of 8 highly skilled and dedicated employees supporting drug substance manufacturing and continuous improvement on our processes and procedures.

Job description

In this role you will assess drug substance quality through review of solution lot records and batch production records and through being on the floor during manufacturing as applicable. You will maintain the quality system related to the exceptions and disposition processes based on current GMP, GDP and regulatory requirements. It is essential to adhere to the global quality system and support the Drug Substance Manufacturing organisation in appropriate handling of exceptions.

You will interact with several onsite departments as well as all other QA functions locally and globally. Primary goal is to support timely release of drug substance by review and approval of solution lot records, batch production records, and master batch records and to facilitate timely handling of deviations related to drug sustance manufacturing

You will be providing input to QA and Drug Substance Manufacturing management regarding issues with the manufacturing process and/or batch documentation that could delay or prevent timely release of drug substance

Main tasks:

  • Perform timely QA review and approval of batch documentation for drug substance through assessment of the process parameters, solution lots, and batch production records
  • Perform batch release for drug substance Approve and perform risk determination of exceptions
  • Act as primary QA contact for the DSM Manufacturing Documentation team, Manufacturing Management, Engineers, and Manufacturing Associates when investigations are ongoing to resolve deviations and/or CAPAs related to the manufacturing process for drug substance.
  • Perform review and approval of documentation, deviations, CAPA etc. in connection to batch disposition, approve process changes and approve SOPs
  • Participate in execution of audits and inspections and act as subject matter expert

Qualifications

You preferably hold a Master of Science, e.g. Pharmacy, Biotechnology, Biology or similar.

You have minimum 4 years of work experience within the pharmaceutical industry, preferably in Quality Assurance. You have solid GMP knowledge and QA and/or manufacturing experience from the pharmaceutical industry that allows for understanding of the complexity of manufacturing biologics. Experience from Automated manufacturing systems or electronic batch documentation would be an advantage.

You have the ability to work in a dynamic environment with a clear sense of urgency. You focus on details but are able to keep the overview and a holistic approach. You take ownership over your work and are able to independently resolve a variety of issues without close supervision. You have good interpersonal skills and enjoys cooperation with colleagues on different levels locally and globally.

Please upload your CV and cover letter latest by 20th of October.

FUJIFILM Diosynth Biotechnologies is a world leading cGMP Contract Development and Manufacturing Organisation (CDMO) with over 25 years’ experience. As a world leading CDMO we combine technical leadership in cell culture, microbial fermentation and gene therapies with state of the art GMP manufacturing, from our network of four global locations in the USA, UK and DK. We currently employ over 2,000 dedicated staff who have a reputation for excellent customer service, flexibility and responsiveness.

As part of FUJIFILM Diosynth Biotechnologies , you will be an active contributor in the advancement of tomorrow’s medicine. We take pride in enriching our communities, caring for our environment and cultivating a world of opportunity for future generations. We invest in you and what you care about, getting the right work-life balance for your health, you family and your professional growth.

FUJIFILM Diosynth Biotechnologies offers a healthy work environment that promotes individual responsibility, allowing you to grow and progress. We support our employees with programs that motivate and educate, promoting a healthy work-life balance that ultimately increases personal well-being and employee satisfaction.

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