Description

You will manage technical documentation and validation deliverables within a GxP regulated environment.

Responsibilities

• Develop and execute commissioning, qualification, and validation documents for manufacturing equipment, utilities, and facilities.
• Document changes related to product workload migration between cloud environments.
• Write detailed Standard Operating Procedures (SOPs), Work Instructions, and Risk Assessments for equipment operation, cleaning, and maintenance.
• Manage protocol deviations, investigations, corrective/preventive actions (CAPA), and change controls.
• Ensure all documentation complies with established company standards and GxP policies.

Required Skills

• 5+ years of experience in technical writing and GxP documentation within the healthcare industry.
• In-depth understanding of GxP requirements and Good Documentation Practices (GDP).
• Proficiency in Microsoft Word formatting for technical document creation.
• Experience authoring and validating commissioning, qualification, and validation deliverables.
• Proven ability to conduct investigations and implement corrective/preventive actions.
• Strong critical thinking and problem-solving skills for managing protocol deviations.
• Ability to manage multiple tasks and interact effectively with cross-functional teams.
• Bachelor's or Master's degree.

Key Skills

Education

Bachelors or Master's degree