Manufacturing Batch Record Coordinator
Welcome to Novartis, a global healthcare company dedicated to improving and extending lives through innovative medicines and technologies. We are currently seeking a highly organized and detail-oriented Manufacturing Batch Record Coordinator to join our team. In this role, you will be responsible for managing the creation, review, and maintenance of batch records for our manufacturing processes. If you have a strong background in manufacturing and a passion for ensuring quality and compliance, we invite you to apply for this exciting opportunity.
- Create and maintain accurate and up-to-date batch records for all manufacturing processes.
- Review batch records for completeness, accuracy, and compliance with company standards and regulatory requirements.
- Collaborate with cross-functional teams to ensure timely completion of batch records and resolve any discrepancies or issues.
- Continuously monitor and track the progress of batch record creation and review, ensuring adherence to established timelines.
- Identify and implement process improvements to enhance the efficiency and accuracy of batch record management.
- Conduct regular audits of batch records to ensure compliance with internal and external quality standards.
- Provide training and support to manufacturing personnel on proper batch record completion and maintenance.
- Coordinate with regulatory agencies during audits and inspections to provide necessary batch record documentation and address any findings.
- Communicate any changes or updates to batch record procedures and requirements to relevant stakeholders.
- Maintain a high level of attention to detail and accuracy in all batch record-related tasks to ensure product quality and regulatory compliance.
Knowledge Of Good Manufacturing Practices (Gmp): The Manufacturing Batch Record Coordinator At Novartis Must Have A Thorough Understanding Of Gmp Regulations And Guidelines To Ensure Compliance During The Manufacturing Process.
Experience In Batch Record Management: This Position Requires Prior Experience In Managing Batch Records, Including Creating, Reviewing, And Revising Batch Records In A Pharmaceutical Manufacturing Environment.
Attention To Detail: As A Manufacturing Batch Record Coordinator, Attention To Detail Is Crucial To Ensure Accuracy And Completeness Of Batch Records, Which Are Essential For Maintaining Product Quality And Meeting Regulatory Requirements.
Organizational Skills: The Ability To Effectively Manage And Organize A Large Volume Of Batch Records, Including Maintaining A Filing System, Is Essential For This Role.
Strong Communication Skills: The Manufacturing Batch Record Coordinator Must Have Excellent Communication Skills To Collaborate With Various Departments, Such As Production, Quality Assurance, And Regulatory Affairs, To Ensure Batch Records Are Completed Accurately And On Time.
Communication Skills
Time Management
Attention to detail
Quality Control
Compliance Knowledge
Document management
Teamwork
Organization
Batch record review
Problem-Solving
Record
Process Auditing
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Manufacturing Batch Record Coordinator in Morris Plains, NJ 07950, USA is $45,000-$65,000 per year. This can vary depending on the specific company, experience level, and other factors.
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Novartis AG develops, manufactures, and markets healthcare products. It operates through the following segments: Pharmaceuticals, Alcon, Sandoz, Vaccines & Diagnostics, and Consumer Health. The Pharmaceuticals segment provides patent-protected prescription medicines. The Alcon segment offers surgical, ophthalmic pharmaceuticals, and vision care products. The Sandoz segment provides generic pharmaceuticals. The Vaccines & Diagnostics segment provides human vaccines and blood testing diagnostics.
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