AbbVie
Sr. Quality Engineer - Quality Risk Management
AbbVie, Chicago, Illinois, United States,
Job Description
Purpose
Describe the primary goals, objectives or functions or outputs of this position.
The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant.
Supports the Quality Engineering group by auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks assigned by the MQA Section Manager and/or the Plant QA Manager.
Responsibilities
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
Monitors Risk Management Program for the site to ensure it is in compliance with AbbVie policies and procedures in addition to all federal/state/global/local and pharmaceutical regulations.
Facilitates Risk Management activities (e.g., FMEA or any other Risk Management activities as specified in local and/or global procedures). Participates in Global and Local Risk Management documentation changes and change control activities.
Responsible for implementing and maintaining the effectiveness of the Quality System.
Support the ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events and places product on QA hold where appropriate.
Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
Approves standard operating procedures; ensures procedures comply with policy and make sense.
Approves calibration requests and ensures that these requests have appropriate product/process limits assigned.
Auditing of commissioning and validation documentation.
Develops product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses and FMEA’s. Develops and implements statistical quality programs and process monitoring systems.
For specific U.S. manufacturing sites, performs batch release.
Provide Risk Management training as required.
Purpose
Describe the primary goals, objectives or functions or outputs of this position.
The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant.
Supports the Quality Engineering group by auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks assigned by the MQA Section Manager and/or the Plant QA Manager.
Responsibilities
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
Monitors Risk Management Program for the site to ensure it is in compliance with AbbVie policies and procedures in addition to all federal/state/global/local and pharmaceutical regulations.
Facilitates Risk Management activities (e.g., FMEA or any other Risk Management activities as specified in local and/or global procedures). Participates in Global and Local Risk Management documentation changes and change control activities.
Responsible for implementing and maintaining the effectiveness of the Quality System.
Support the ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events and places product on QA hold where appropriate.
Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
Approves standard operating procedures; ensures procedures comply with policy and make sense.
Approves calibration requests and ensures that these requests have appropriate product/process limits assigned.
Auditing of commissioning and validation documentation.
Develops product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses and FMEA’s. Develops and implements statistical quality programs and process monitoring systems.
For specific U.S. manufacturing sites, performs batch release.
Provide Risk Management training as required.