We are seeking an experienced Technical Writer to join the Technical Operations Compliance team, supporting automated systems and maintenance program documentation. In this role, you'll liaise with cross-functional teams, including Automation and Validation, to produce comprehensive reports, manage SOP revisions, and ensure data accuracy and regulatory compliance.
Key Responsibilities:
- Collaborate with Automation and Validation teams to generate Automated System Periodic Evaluation (PER) reports.
- Create and manage maintenance reports by reviewing and trending work records, coordinating with various departments for data validation.
- Review and revise departmental SOPs, lifecycle documents, and policies, ensuring adherence to ALCOA+ principles.
- Facilitate preventative maintenance and audit trail reviews, supporting audit preparation through detailed documentation.
- Administer equipment access for Automation and stay current with cGMP requirements.
Ideal Candidate Profile:
- Experience in a regulated GxP environment.
- Proactive and capable of working independently.
- Strong project management, communication, and collaboration skills.
- Detail-oriented with a focus on meeting deadlines and maintaining compliance standards.
If you thrive in a fast-paced environment and have a passion for technical writing within regulated settings, this role could be a great fit for you!
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
