Pharmaceutical Compliance Specialist

• 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 cross-functional training.
• Work in a GMP-regulated environment to provide and assist in the implementation of quality-related activities.
• 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
• Coordinate workflow and perform daily monitoring to meet TAT
• Perform and/or assign other duties as requested to ensure the smooth operations of department

Qualifications :

• Bachelors 2 years of relevant industry experience or Masters degree in a scientific field such as Pharmacy Biology or Chemistry 
• Pharmaceutical industry experience
• Strong knowledge of global regulatory and cGMP requirements industry best-practices
• Experience with manufacturing operations.
• Strong technical writing ability

Additional Information :

• Position is full-time Monday-Friday 8:00 AM - 4:30 PM
• Pay range: $26.25 - $30.00
• Excellent full-time benefits including comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Eligibility for potential yearly Bonus & Merit-Based Pay Increases
• LinkedIn: #LI-EB1

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time