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The EC Investigator is responsible for investigating environmental monitoring deviations within cleanroom environments to ensure compliance with regulatory standards and SOP policies and procedures. This role involves conducting thorough root cause analysis, assessing the impact of events to product and cleanroom, and collaborating with cross-functional teams to implement corrective and preventive actions. The EC Investigator plays a key role in maintaining product quality, regulatory compliance, and ensuring a safe and controlled cleanroom environment.
Key Responsibilities:
· Investigation of Deviations:
o Respond to and investigate environmental deviations within cleanroom environments, including abnormalities in air quality (e.g., particulate levels, airflow), temperature, humidity, pressure, SOP violations, and microbial contamination that exceed limits.
o Document deviations thoroughly, providing clear descriptions of the issue, potential causes, and any immediate corrective actions taken.
o Conduct root cause analysis (RCA) of deviations, utilizing tools such as the 5 Whys, Fishbone diagrams, or Failure Mode Effects Analysis (FMEA) to identify underlying issues.
· Impact Assessment and Risk Evaluation:
o Assist in assessing the impact of deviations on product quality, safety, and regulatory compliance by providing information to determine whether the deviation poses a risk to the safety of the product, personnel, or the environment.
o Communicate findings to quality assurance, production, engineering, and affected personnel when appropriate, to ensure proper understanding of the deviation's implications and adhere to any remediation actions associated with the event investigating.
· Documentation and Reporting:
o Maintain accurate records of all deviations, including investigation reports, trending data, and any correspondence with interdepartmental personnel and leadership.
o Prepare detailed deviation reports that are compliant with Good Manufacturing Practices (GMP), ISO standards, and other applicable regulatory guidelines.
o Provide regular status updates and reports on open investigations to management.
· Collaboration with Cross-Functional Teams:
o Collaborate with the quality assurance (QA), engineering, and manufacturing teams to ensure that cleanroom conditions are maintained according to established standards and specifications.
o Assist in training cleanroom personnel on the importance of environmental monitoring, the identification of deviations, and reporting protocols.
· Regulatory Compliance:
o Ensure all cleanroom deviations are handled in accordance with relevant regulatory guidelines, such as FDA, EMA, ISO 14644 (Cleanroom Standards), and other industry-specific requirements.
o Support audits and inspections by providing necessary deviation records, investigation reports, and CAPA evidence.
· Continuous Improvement:
o Analyze trends in deviation data to identify potential systemic issues or recurring problems and recommend process improvements to minimize the occurrence of future deviations.
Distinguiti dagli altri
Profile/Experiences:
· Degree your related experience in biotechnology, Pharmaceutical Sciences, Environmental Science, Chemistry, Engineering, or related field.
· Experience in cleanroom environments (e.g., pharmaceutical, biotechnology, medical device manufacturing).
· Experience in environmental monitoring, quality assurance, or compliance roles.
· Prior experience investigating deviations or conducting root cause analysis (RCA) is beneficial.
· Familiarity with GMP and ISO 14644 standards is desirable.
· Strong problem-solving and root cause analysis skills to identify issues, assess impacts, and recommend corrective actions.
· High level of attention to detail in reviewing data, identifying deviations, and ensuring thorough documentation and compliance.
· Excellent written and verbal communication skills for reporting, documentation, and cross-functional communication.
· Ability to manage multiple investigations, track implementation, and meet deadlines.
· Ability to work well with cross-functional teams, including QA, production, engineering, and regulatory affairs.
· Familiarity with environmental monitoring systems (e.g., air particle counters, HVAC systems, temperature/humidity controls) and deviation management software.
· Experience analyzing data trends to identify potential areas for improvement in environmental control systems.
Cosa offriamo
Fagron offers exciting opportunities for personal and professional growth, which supports and encourages you to develop your skills and talents. Be part of a collaborative culture that rewards you with competitive compensation, an extensive benefits package and a truly open and dynamic work environment.