LSC have a great contract opportunity for a Technical Writer to join a Cork based Biopharmaceutical company.
If you have at least 2+ years of relevant experience in a cGMP environment and ready for your next challenge, this could be the perfect project for you!
Join Our Team as a QC Technical Writer - Elevate Compliance & Documentation Excellence!
Are you passionate about precision, clarity, and compliance in a fast-paced regulated environment? We are on the hunt for a meticulous and dedicated QC Technical Writer to play a pivotal role in ensuring the accuracy and quality of essential technical documentation. This is your chance to be a vital part of a dynamic team committed to operational excellence, regulatory compliance, and continuous improvement. If you thrive in collaborative settings and have a knack for translating complex technical information into clear, compliant documentation, we want to hear from you!
Key Responsibilities:
- Author, review, and redline technical documents using the Veeva platform to ensure clarity, accuracy, and adherence to regulatory standards.
- Assist with training system administration, including curriculum updates, managing enrollments, tracking compliance, and handling administrative tasks.
- Collaborate cross-functionally to ensure documentation aligns with GMP standards and regulatory requirements.
- Maintain detailed records of document revisions and training activities to support audits and regulatory submissions.
- Support onboarding and ongoing compliance training initiatives, ensuring seamless training administration.
Required Skills:
- Degree in a Science or Engineering discipline.
- 2+ years of proven technical writing experience within a regulated environment.
- Familiarity with Veeva or similar document management platforms.
- Experience with compliance tracking and training administration systems (e.g., Compliance Wire).
- Knowledge of GMP standards and regulations.
- Strong attention to detail and excellent organizational abilities.
- Ability to communicate complex technical information clearly and effectively.
Nice to Have Skills:
- Experience with further document management tools.
- Background in additional regulated industries.
- Certifications related to technical writing or compliance best practices.
Other Requirements:
- Successful candidates should be comfortable working in a regulated environment, with attention to accuracy and confidentiality.
- Ability to collaborate effectively across multifunctional teams.
- Prior experience with audit readiness or regulatory submissions is advantageous.
Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa. Please understand that we are unable to provide visa sponsorship. Thank you for your understanding.
Apply via this advert or contact Jenny Murphy at LSC on 021-4777329 if you have any more questions about this opportunity!
