Reporting to the Manager, QA Manufacturing Operations, the Senior Specialist, QA Manufacturing Operations will support the execution and maintenance of the QA activities related to Manufacturing operations and site operations on shift in Cruiserath. This is a 24/7 shift role.

Key Duties and Responsibilities:

* QA support of manufacturing operations (commercial operations and new product introductions)
* Batch record review and on the-floor support of manufacturing activities
* QA Operations review of events and investigations
* Authoring, review and approval of QA-related procedures
* Review and approval of functional area documentation
* Support the Disposition process for Drug Substance
* Participation in GMP reviews for new facility construction and new equipment support systems
* QA support for implementation of Manufacturing Execution System (MES) and development of batch records
* QA support for implementation of the System (SAP) including data verification and integration testing for the Quality function.
* Change control assessment and CAPA evaluation/CAPA close-out.
* Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
* Support OpEx programs and champion continuous quality improvement initiatives.

Qualifications, Knowledge and Skills Required:

* BSc in Science or related discipline with a minimum of 2 years' QA Operations or related experience in a Biologics or Pharmaceutical environment
* A clear understanding of cGMP requirements for manufacturing and/or systems and compliance
* Detailed knowledge of Biologics Processing would be a distinct advantage.
* Required to work on his/her own initiative in addition to working as part of a team, and must be open to shift work. Must be able to work across a team matrix in order to meet accelerated timelines
* Excellent communication and presentation skills are essential
* Excellent time management and organisational skills along with a proven ability to multi-task

The Next Step for you:

Interested in this role? Please send your CV to Raquel Lourenco at Next Generation Recruitment by clicking on the Apply button!

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