Documentation Specialist

10 Apr 2018
24 Apr 2018
Justin Pankinas
Job Type
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. Ensure that objectives are effectively achieved, consistent with the company requirements to ensure compliance, safety and reliable supply to our customers.
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 associated within the Vaccine IPT.
He/She will contribute to the High-Performance culture within the Vaccine IPT by providing a flexible, accurate service to enable the IPT to achieve four key priorities.
The Documentation Specialist is an active member of the cross functional IPT Team, providing support, guidance and expertise to ensure the success of the Vaccine IPT.
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
*Investigation Support
*Issuance of documents to the Operations Department
*Any other duties assigned by your lead.

Key Experience:
*Computer literacy.
*Strong communication skills.
*High level of technical aptitude
*Demonstrated initiative and pays attention to detail
*Good presentation skills.
*Highly disciplined and organized
*Ability to organise & coach less experienced colleagues in the group
*Good social skills
*Ability to work as part of a team

*4+ years experience of working in a similar documentation related role in the Pharmaceutical Industry