Job Title: GMP Documentation Specialist
Location: Albany, NY (Fully Onsite)
Duration: 6 months with likely extension
Job Description:
Our client is a large biotechnology company looking for a SME to help them support their batch record releases. They have commercial sites in the US and are working on their commercial space in Canada. Their site in Canada has several clinical studies that they are doing a first-time release.
They need someone who knows the Health Canada Guidelines well, and someone who has or can make trainings for them. They want to understand what the difference is between what they are currently doing and what they are expected to be doing (like a gap assessment).
Requirements:
1. Knowledgeable of GUI-0036 Guidance Document - Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines Drugs Used in Clinical Trials
Especially section, 10.0 Release of batches and how to execute and document the requirements of this section.
Able to produce documentation that satisfies section 11, step 44: Investigational medicinal products should remain under the control of the Sponsor until after completion of a twostep release procedure: certification by the Qualified Person; and release following fulfilment of the relevant requirements. The sponsor should ensure that these are consistent with the details considered by the Qualified Person. Both releases should be recorded and retained in the relevant trial files held by or on behalf of the sponsor.
Experience generating label reviews
Understanding of what is required for label reviews and potentially have pre-prepared templates that can be utilized.
Expert in GUI-0036 and GUI-0100 regulations
Understanding of Clinical GMP expectations, and systems in place that REGN can utilize for release by the consultant
Bonus Requirements:
Experienced in hosting Audits by Health Canada And their processes be in place and in use for previous clients that have been audited
Able to provide training to Client Personnel on GUI0036 and GUI-0100, including Health Canada audit expectations, and differences between FDA and Health Canada expectations
Able to consult Client for setting up of applicable inhouse systems
Able to identify gaps in Client’s processes, so that they can be remediated
Potential to write reports identifying gaps and other applicable requirements that are necessary.
Background Requirements:
Must hold a university degree; in Canada this must be a Canadian university degree or a degree recognized as equivalent by a Canadian university or Canadian accreditation body in a science related to the work being carried out.