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