QA Operations Expert DS

Posté 12 janv. 2023

Aubonne, Vaud - Switzerland

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Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 


As part of the DS Quality team, your role will be to ensure that drug substance batches, manufactured internally or externally, for market, development or validation purpose meet the appropriate quality requirements and are in compliance with currenGood Manufacturing Practices (cGMP's) and any applicable regulatory filings and Merck quality standards.

 

Compliance

You will be in charge of ensuring compliance of Drug Substances manufacturing processes and batches by development stages, including product specifications with internal and external regulations and regulatory filings. You will also manage the deviations and ensure implementation of appropriate corrective / preventive actions. Furthermore, your duties also involve supporting, evaluating and approving CCPs related to drug substance manufactured at Aubonne.

You will be reviewing the production and environment trends and coordinate investigation/deviation where necessary and establish the GMP certificate of Conformity for IMPs. You will apply the risk based approach on a routine basis in all activities managed in its field of

expertise and contribute to the writing of QA procedures. Finally, you will be in charge of Escalating Risk linked to process development in a timely manner to the local QM, communicate risk to Product Quality Leader according to internal alignment with QM and BPS

and Participate and maintain alignment between DP & analytics development department.

 

Manufacturing Control and Batch Release

You will be in charge of reviewing Manufacturing Batch Records and performing usage decision on in-house manufactured Drug Substance batches and batch certification. You will also edit Certificate of Analysis for Drug substance batches manufactured at Aubonne and contribute to the monthly review of key quality indicators related to the manufacture and the release of Drug Substance batches.

 

Replacement

- In case of absence, the responsibility for compliance, manufacturing control and batch release

is delegated to other QA DS release Expert.

- Deputy of the Technical Responsible / Qualified Person for batch disposition decisions.

 

Your profile: 

  • At least 7 years of experience in the pharamaceutical industry
  • With a relevant experience in a Quality function
  • Strong Knowledge of cGMPs and applicable regulations to manufacturing of DS
  • Good knowledge of Biotec manufacturing process is mandatory
  • English level B2, Fluent in French, Any other languages is an asset
  • Master/ Ph.D in pharmaceuticals / life science or any related field. 

 



What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

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