Project:
The expert will collect data/information across all functions; Manufacturing, Production, Quality/Regulatory etc from the Audits in order to create technical responses & documents which the Client will submit back to the FDA post audit.
The project is eight weeks starting April 14th. The first 3 weeks are fully on site, the role is more flexible for the remaining five weeks. The site is based near Bandon, Cork.
Key Responsibilities:
1. Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Research & Development & Manufacturing to gather and analyze data related to post-audit findings.
2. Develop comprehensive technical documents and responses tailored to the specific requirements of the FDA.
3. Organize & collate all of the information & documentation into a coherent document.
4. In the words of the manager: organize the data in the technical document & tell the story in a coherent way, that can be submitted to the FDA as part of our response.
5. They will also be inspected by the Korean & Turkish health authorities - experience with these regulations is nice to have but not essential; the FDA experience is however.
6. The function of expert will be more execution as opposed to consultative. They don't need guidance on which data to input, rather a steer on how to formulate a coherent & accurate Technical Document.
Profile
1. Minimum of 3 years of experience in technical writing within the pharmaceutical or biotechnology industry.
2. Proven expertise as a Technical Writer & with responding to FDA audits.
3. Exposure to c-GMP & FDA regulations.
4. Exceptional writing, editing, and communication skills with a keen attention to detail.
5. Ability to translate complex scientific concepts into clear, concise, and accurate technical documents.
6. Site is a vaccines manufacturer, so experience with large molecules would be ideal.
On site: fulltime on site for three weeks outside Bandon, remaining five weeks are more flexible.
Start Date: 14th of April.
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