Third Party Supplier (3PS) CMC Associate

CMC Team

Hays Life Sciences is now looking to recruit a Third Party Supplier CMC Associate to join the CMC team for a 12-month contract assignment with the possibility of an extension at AstraZeneca in Södertälje.

AstraZeneca is operating as a supplier for divested products where the manufacturing licence is now owned by an external partner. As part of this relationship there is a requirement to ensure that AstraZeneca manufacturing network has full visibility and access to the current regulatory approved Chemistry Manufacturing and Controls (CMC) dossier for each country where the product is marketed. This is critical in ensuring that products are manufactured in compliance with the licences held by the third party licence holder.

We are looking for 3PS CMC Associate to join our CMC team focused on divestment related activities located in Södertälje.

The role
You will liaise with internal CMC and QA specialists and external partners and be responsible for the upload of CMC documents into a document management system. Compliance with established good documentation practices such as version control, ensuring business approval and document format will be part of this work. Communication of any changes to this information, such as new market approved documents, to the relevant manufacturing sites is also a critical success factor.

Additionally, you will be required to ensure that AstraZeneca's change control system is maintained to reflect regulatory assessments supplied by the third party. You will responsible for the upload of documents provided by external partners and for communication to relevant manufacturing sites.
You will be participating in the improvement of processes required to achieve the above.

Minimum Requirements - Education and Experience

* Degree in Chemistry or Pharmacy or Chemical Engineering, or equivalent experience
* Fluently spoken and written English and Swedish
* Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs

Skills and Capabilities

* Experience from and interest of using Document Management systems
* Attention to details, highly organized, able to plan and control own workload effectively and manage expectation of others
* Ability to work with short and / or changing timelines
* Able to work collaboratively with customers and colleagues to achieve optimum outcomes
* Excellent written and verbal communication skills
* IT software skills