Documentation Specialist

This role will be responsible for supporting the Vaccine Compliance & Documentation Group in the management of the IPT GMP documentation, and in supporting the Compliance Documentation functions in various administrative duties. This requires the delivery of compliance excellence to deliver all components Good Documentation Practices, supported by a flexible, collaborative, multi-skilled teamwork environment.

Key Responsibilities:

The Documentation Specialist is accountable for the smooth execution of all appropriate documentation.
He/She will contribute to the High Performance culture within the department by providing a flexible and accurate service to enable the IPT to achieve key priorities.
The Documentation Specialist is an active member of the cross functional team, providing support, guidance and expertise to ensure the success.
The Documentation Specialist will participate and comply with the Quality Management System (QMS) requirements, including ownership, as relevant to you.

Primary activities/responsibilities:
Updating of procedural documents.
Preparation of change control documentation.
Processing of documentation through the Change Control System.
Review of batch records and recording of incidences of corrections made to batch records. Generation and control of protocols.
Quality & Safety Compliance monitoring including reporting, metrics, etc.
Issuance of documents to the Operations Department