Sr Technical Writer

Required Competencies:
Knowledge, Skills & Abilities:Exceptional technical writing skills, including proficiency in Microsoft Word formatting, ensuring the creation of technically accurate documents in line with validation programs.Process-oriented with strong critical thinking and problem-solving abilities.In-depth understanding of GXP requirements and good documentation practices within the pharmaceutical industry.Experience in creating Standard Operating Procedures, Work Instructions, Risk Assessments, and authoring/validating commissioning/qualification/validation deliverables.Ability to handle protocol deviations, conduct investigations, and implement corrective/preventive actions.Strong organizational skills to manage multiple tasks in a fast-paced environment.Excellent written and verbal communication skills, with the ability to present information clearly and interact effectively with cross-functional teams.

Key Responsibilities:Develop and execute commissioning, qualification, and validation documents for manufacturing equipment, utilities, and facilities.Handle protocol deviations, investigations, corrective actions, and change controls as needed.Write detailed procedures for the operation, cleaning, and maintenance of equipment.Ensure all documents comply with company standards and policies.Provide excellent customer service and foster positive relationships with team members and site customers.