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Novartis

Compare

4.1

based on 1.6k Reviews

228 Novartis Jobs

Specialist - MS&T

Novartis Healthcare Pvt. Ltd.

4.1

based on 1.6k Reviews

5-10 years

₹ 6.35 - 20L/yr (AmbitionBox estimate)

Hyderabad / Secunderabad

1 vacancy

Specialist - MS&T

Novartis

posted 2mon ago

Job Role Insights

Flexible timing

Key skills for the job

Software Configuration Management Technical Writing Auditing HSE Continuous Improvement Document Management

+ 3 more

Job Description

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.

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