- Work in a GMPregulated environment to provide and assist in the implementation of qualityrelated activities.
- Develop a comprehensive set of quality metrics aligned with organizational goals and industry standards. This involves collaborating with stakeholders to identify key performance indications (KPIs) and defining measurable objectives.
- Collaborating with cross functional client Quality and other PSS site team.
- Collecting data from various process areas defect reports and performance metrics. Analyze the data to identify trends patterns and areas of improvement.
- Generate regular investigation training reports to provide visibility into quality performance. Manage quality improvement activities meetings and other activities supporting the work of the departments.
- Presenting and Communicate quality related metrics trends and insights to stakeholders at various level of the organization. Present findings in meetings reviews and reports to facilitate informed decision making.
- Evaluate and managing resources and task understanding department needs to evaluate resources needed by implementing the Capacity model system and crossfunctional training.
- Assist with other aspects of quality improvement including administrative and operational support as needed.
- Drive continuous improvement efforts through monitoring/evaluation of site systems & processes aligned with GMP and FDA requirements. To ensure adherence with quality standards and best practices.
- Evaluate the thoroughness and effectiveness of the training program. Foster a culture of quality awareness and continues improvement throughout the organization.
- Provide oversight of systems to ensure compliance with internal policies procedures and guidelines.
QA Essential Duties and Responsibilities:
- Applies GMP/GLP in all areas of responsibility as appropriate
- Demonstrates and promotes the companys vision
- Regular attendance and punctuality
- Ensure that the quality policy program is understood implemented and maintained at all levels of the organization; identify prevent or correct any departures from the quality system
- Perform work for both routine and nonroutine work as specified by separate and applicable technical job descriptions for individual
- Develop and implement operational improvements
- Supervise others in performing clients service requirements
- Coach train and develop others within the group with respect to their personal development and effective implementation of operational improvements
- Coordinate workflow and perform daily monitoring to meet TAT
- Conduct semiannual performance reviews interview applicants keep training records up to date for assigned employees perform succession planning in preparation for growth
- Confront and address problems concerns and performance issues
- Coach and develop individuals and teams to maximize performance
- Foster motivation and morale
- Monitor and approve employees time worked through timeentry system
- Support and promote company policies and procedures
- Expand selfawareness and develop leadership skills as defined; attend applicable leadership training based on identified needs
- Perform and/or assign other duties as requested to ensure the smooth operations of department
Qualifications :
Education Requirements:
- Preferred Masters or Minimum Bachelors degree in a Science / technical field such as Pharmacy Biology Chemistry or Engineering.
Basic Minimum Qualifications:
- Minimum of five years experience in the pharmaceutical industry and/or FDA experience Quality Assurance/Compliance.
- Experience in a leadership role within quality overseeing quality labs.
- Strong knowledge of global regulatory and cGMP requirements industry bestpractices
- Strong familiarity with production operations.
- Strong leadership project management and technical writing.
Additional Information :
#LIEB1
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Fulltime