Luza Tecnologia is a Portuguese start-up that is part of the Belgian group, De Cronos Groep. We are characterized by our commitment to our people, their well-being, and development.Job Description This is a remote position.As a Pharmaceutical Compliance Manager , your primary mission is to ensure that the organization adheres to all relevant regulations, guidelines, and quality standards specific to the pharmaceutical industry. Here are the key responsibilities:Regulatory Expertise :Deep Understanding : Develop an in-depth knowledge of pharmaceutical regulations, including FDA guidelines , ICH GCP , and other relevant standards.Application : Apply this expertise to assess and maintain compliance across all aspects of the organization's operations.Quality Systems Oversight :Control Systems : Develop and oversee robust control systems to prevent or address violations of legal guidelines and internal policies.Risk Assessment : Regularly evaluate the efficiency of controls and continuously improve them.Hidden Risks : Periodically revise procedures, reports, and processes to identify hidden risks or non-conformity issues specific to pharmaceutical operations.Computer System Validation (CSV) :Critical Role : Ensure that computerized systems used in pharmaceutical processes comply with FDA's 21 CFR Part 11 requirements.Validation Phases : Oversee the entire CSV process, including Installation Qualification (IQ) , Operational Qualification (OQ) , and Performance Qualification (PQ) 1 .Audit Management :Internal and External Audits : Coordinate audits effectively.Address Findings : Address audit findings promptly and implement corrective actions.Mitigate Risks : Use audit outcomes to mitigate potential compliance risks.Ethical and Data Privacy Considerations :Ethical Behavior : Uphold ethical standards within the organization.Data Privacy : Safeguard sensitive information, especially patient data, in compliance with privacy laws (e.g., HIPAA ).Collaboration and Communication :Stakeholder Engagement : Collaborate with cross-functional teams, including R&D, clinical, manufacturing, and regulatory affairs.Effective Communication : Clearly communicate compliance policies, guidelines, and expectations to all relevant parties.Proactive Measures : Identify and assess risks related to compliance.Prevent Violations : Develop strategies to prevent compliance breaches.Quality Assurance and Validation :Laboratory Compliance : Ensure compliance with laboratory software testing and validation requirements.Release of Pharmaceuticals : Prior experience in testing and release of chemicals and pharmaceuticals is valuable.Industry-Specific Knowledge :Pharmaceutical Landscape : Stay informed about industry-specific guidelines, trends, and best practices.FDA Inspections : Prepare for and manage FDA inspections effectively.Leadership and Influence :Change Management : Drive compliance initiatives across the organization.Influence Culture : Foster a culture of compliance and quality.Remember, as a Pharmaceutical Compliance Manager , you play a pivotal role in ensuring patient safety, product quality, and regulatory adherence. Your commitment to excellence directly impacts public health and the success of pharmaceutical operations.#J-18808-Ljbffr
