Our client is seeking to recruit an agency/contingency worker as Senior Specialist, QA Operations on a 12 month contract. Reporting to the Senior Manager, QA Operations, the successful candidate will support the execution and maintenance of the QA activities related to Manufacturing operations and site operations on a 4-shift rotation.

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 the Enterprise Resource Planning 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 minimum 2 years’ QA Operations experience in a biologics (Drug Substance preferable) / pharmaceutical environment

• A clear understanding of cGMP requirements for manufacturing and/or systems and compliance

• 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