Monitor key quality system metrics, process indicators, and overall health of the cGMP Quality Management System (QMS) to proactively identify and address quality systems or product issues and ensure its continuing stability, effectiveness, and improvement.

More Uses of the cGMP Toolkit:

  • Manage work with process development team and operations organization to successfully transfer process to cGMP facility to manufacture products.
  • Assure the analytical team follows applicable cGMP requirements and your organizational SOPs.
  • Ensure you conceptualize; lead the design, commissioning and implementation of control and automation engineering projects in cGMP manufacturing areas and supporting labs.
  • Be accountable for supporting process development, design, scale up, technology transfer, and start up of cGMP manufacturing.
  • Provide training and support to Product Development personnel during the development and scale up of formulations on cGMP equipment.
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
  • Maintain compliance with applicable cGMP regulations, vendor guidelines, engineering.
  • Confirm your corporation ensures timely completion and compliance with cGMP and all other relevant organization training requirements.
  • Ensure you educate; understand and adhere to SOPs and cGMP compliance regarding materials control in multiple storage locations and conditions.
  • Provide leadership and oversight to the capital team to ensure a cGMP facility is built to meet regulatory and client requirements.
  • Perform review, audit, and approval of manufacturing batch records and protocols to ensure production records are complete, accurate, and documented according to written procedures and cGMP requirements.
  • Write manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
  • Be accountable for assuring that all test data is gathered and recorded in accordance with cGMP requirements.
  • Be accountable for the Quality and cGMP compliance of the area by ensuring cGMP is followed in area of responsibility.
  • Ensure all operations are executed in cGMP compliant manner and meet organization standards.
  • Organize validation activities with related areas, samples collection, data analysis and Involved in the development of SOPs and validating laboratory equipment as per cGMP regulations.
  • Identify, prioritize, and execute quality improvement efforts to continually improve efficiency, effectiveness, and compliance with applicable cGMP regulations.
  • Lead process development, design and improvement in the manufacturing of consumable products or support of processes/equipment used in a cGMP manufacturing environment.
  • Make sure that your team operates production equipment and performs duties under compliance of cGMP manufacturing.
  • Establish: review requirements and enforces procedures to ensure cGMP and regulatory compliance.
  • Provide technical guidance and support based on overall project plans with the development of products in compliance with design controls, processes in compliance with Good Manufacturing Practices (cGMP).
  • Initiate: compliance closely collaborate with quality and compliance, and facilities and engineering to maintain a high level of cGMP compliance and safety through the effective monitoring and reporting of metrics.
  • Be certain that your organization complies; employees must also maintain complete and accurate records, in accordance with cGMP.
  • Steer: industry standards for commissioning, qualification, and operation of facilities and utilities for cGMP manufacturing.
  • Perform or support cGMP lot release, in process, and stability testing using various software packages.
  • Ensure your group assures that production operations are performed according to cGMP and ISO 9000 standards.
  • Assure cGMP success through effective tech transfer and support of cGMP manufacturing.
  • Perform inventory transactions and support inventory management functions using ERP system in a cGMP environment.
  • Manage work with process development team, quality and operations organization to successfully transfer process to cGMP facility to manufacture products.
  • Be accountable for writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.

 

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