Job Title: Technical Documentation Specialist
Job Description:
This role is responsible for supporting the team by documenting and managing deviations and changes in the manufacturing process. The ideal candidate will have a strong understanding of GMP standards and regulatory requirements, as well as excellent technical writing skills with attention to detail.
Responsibilities & Accountabilities:
• Document deviations, including root cause analysis, corrective actions, and preventive measures.
• Draft and manage change control records, ensuring changes are accurately captured and approved per GMP standards.
• Produce clear, concise technical documents, such as SOPs, work instructions, and reports.
• Ensure documentation aligns with GMP standards and regulatory requirements.
• Partner with production, quality, and engineering teams to gather information and ensure accurate documentation.
• Identify and implement improvements to enhance documentation and change control practices.
• Train and guide staff on deviation and change control procedures.
• Support audits by providing documentation and resolving findings related to deviations and change management.
Required Skills & Qualifications:
• Bachelor's degree in a scientific or technical field (e.g., Life Sciences, Engineering, Technical Writing).
• Minimum of 2-3 years of experience in technical writing, deviation management, or change control, preferably within the pharmaceutical or biotechnology industry.
• Demonstrated experience in documenting deviations and managing change control processes.
• Strong understanding of GMP standards and regulatory requirements.
• Excellent technical writing skills with attention to detail.
• Proficiency in PC applications, including MS Office.
• Strong communication and interpersonal skills.
• Certification in technical writing or quality management.
• Experience with electronic documentation management systems (e.g., Documentum, TrackWise).