What are the responsibilities and job description for the Software Technical Writer position at Proclinical Staffing?
Manufacturing Technical Procedure Writer
Proclinical is seeking a detail-oriented and skilled technical writer to create, revise, and maintain clear and compliant standard operating procedures (SOPs), batch records, and other technical documentation for pharmaceutical manufacturing processes.
This role focuses on ensuring all documentation meets Good Manufacturing Practices (GMP) and regulatory requirements. The successful candidate will possess strong technical writing skills and a solid understanding of pharmaceutical manufacturing processes.
Main Responsibilities:
- Write, edit, and maintain SOPs, batch records, work instructions, and other technical documents.
- Ensure documentation complies with GMP, FDA, EMA, and internal policies.
- Collaborate with manufacturing, quality assurance, validation, safety, and engineering teams.
- Manage document lifecycle using electronic document management systems (EDMS).
- Assist in developing training materials based on SOPs.
Requirements:
- Bachelor's degree in Technical Writing, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or related field.
- Proficiency in technical writing and editing with a focus on clarity and accuracy.
- Understanding of pharmaceutical manufacturing processes and terminology.
- Experience with document management systems and Microsoft Office Suite.
- Ability to collaborate with cross-functional teams and manage multiple projects.
- Knowledge of regulatory guidelines such as 21 CFR Part 211, ICH Q7.
- Certification in Technical Writing or GMP training is preferred.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
