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:
- Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Research & Development & Manufacturing to gather and analyze data related to post-audit findings.
- Develop comprehensive technical documents and responses tailored to the specific requirements of the FDA,
- The technical writer expert will have to organize & collate all of the information & documentation into a coherent document
- 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"
- 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
- 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
- Minimum of 3 years of experience in technical writing within the pharmaceutical or biotechnology industry.
- Proven expertise as a Technical Writer & with responding to FDA audits
- Exposure to c-GMP & FDA regulations
- Exceptional writing, editing, and communication skills with a keen attention to detail.
- Ability to translate complex scientific concepts into clear, concise, and accurate technical documents.
- 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
