Pharmaceutical Compliance Specialist

At Eurofins PSS, we work with leading international companies across the pharma, medical device, food, cosmetic & consumer products industries - who all trust us with their mission-critical testing. For 20 years, our international network of teams have served clients at their sites, across 20 countries.

PSS® is part of Eurofins Scientific, an international life sciences company, providing a unique range of analytical testing services across multiple industries, through a network of over 950 laboratories in 60 countries, and c.a. 63,000 employees.

Responsibilities

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.; Applies GMP/GLP in all areas of responsibility, as appropriate; Demonstrates and promotes the company's 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

Requirements

Bachelor’s + 2 years of relevant industry experience, or Master's degree in a scientific field such as Pharmacy, Biology or Chemistry +1 year of relevant experience.; Relevant experience may include:; Quality investigations, deviations, audits, CAPAs, quality management systems, controlled document storage, etc.; Pharmaceutical industry experience; Strong knowledge of global regulatory and cGMP requirements, industry best-practices; Experience with manufacturing operations.; Strong technical writing ability