Summary
The Technical Writer - Change Control Management is responsible for developing, managing, and maintaining documentation related to change control processes within a regulated manufacturing environment. This role ensures documentation accuracy, consistency, and compliance with regulatory and organizational standards. The Technical Writer will leverage their knowledge of science and manufacturing technologies to collaborate effectively with cross-functional teams, streamline documentation workflows, and support the organization's change control management processes.
About the Role
Key Responsibilities
- Develop, revise, and maintain high-quality documentation related to change control processes, ensuring alignment with cGMP and other regulatory standards.
- Collaborate with cross-functional teams, including Quality, Operations, and Engineering, to ensure all change control documentation is accurate, comprehensive, and aligned with organizational objectives.
- Utilize scientific and technical knowledge to accurately interpret and document manufacturing processes, equipment, and technology changes.
- Manage the lifecycle of change control documentation, including updates, version control, and accessibility for stakeholders.
- Facilitate change control review meetings, capturing key information and translating it into actionable and clear documentation.
- Standardize templates and formats for change control documentation to enhance consistency and usability across the organization.
- Provide support during audits and inspections by ensuring accurate and readily available change control documentation.
- Track and report on metrics related to change control documentation, including timeliness, compliance, and quality.
- Train and mentor team members on documentation best practices and change control management processes.
- Contribute to process improvement initiatives by identifying and addressing gaps in change control documentation workflows.
- Ensure that data integrity checks are conducted to verify that all the data is complete, consistent, and free from errors before proceeding with any further analysis or reporting.
Want more jobs like this?
Get jobs in Hyderabad, India delivered to your inbox every week.
Key Performance Indicators
- Accuracy and compliance of change control documentation
- Timeliness of documentation updates and approvals
- Stakeholder satisfaction with documentation quality and usability
- Adherence to regulatory requirements during audits and inspections
- Effectiveness of standardized documentation processes
Skills:
- Good Documentation Practice
- Effective communicator
- Strong cross functional collaboration
- Adaptability to Embrace Change
- Effective stakeholder engagement
- Manufacturing Process
- Knowledge Of GMP (Good Manufacturing Practices)
- Change Control
- Deviation management
- Corrective and preventive action (CAPA)
- Continual Improvement Process
- General HSE Knowledge
- Manufacturing (Production)
Background
- Education:
Bachelor's degree in a science or engineering-related field (e.g., Biology, Chemistry, Mechanical Engineering, or similar disciplines). - Languages:
English fluent - Experience:
- 5+ years of experience in technical writing, preferably within a regulated manufacturing or scientific environment.
- 2+ year of experience in in drafting and managing change control documentation within GxP settings.
- Strong understanding of change control processes, cGMP, and regulatory compliance.
- Fundamental knowledge of science and/or manufacturing technologies, with the ability to interpret technical and scientific information.
- Proficient in document management systems and technical writing tools.
- Excellent attention to detail, organizational skills, and the ability to manage multiple priorities.
- Experience supporting audits and inspections is a plus.
- Familiarity with Lean principles or continuous improvement methodologies is advantageous.
- Proficiency in English (oral and written) is required
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Division
Operations
Business Unit
Innovative Medicines
Location
India
Site
Hyderabad (Office)
Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area
Technical Operations
Job Type
Full time
Employment Type
Regular
Shift Work
No