Stefanini, Inc
QA Lead, Deviation Investigations
Stefanini, Inc, Baltimore, Maryland, United States,
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Job DetailsPharma Manufacturing/Engineering QA Lead, Deviation InvestigationsHarmans, MDPosted: 8/13/2024Job ID#: 1613Job Category: Pharma Manufacturing/EngineeringDuration: 4 monthsShift: 1Positions Available: 5 As the QA Project Manager for Deviations and CAPA Investigations, you will play a pivotal role in ensuring the integrity of our pharmaceutical manufacturing processes by leading and managing investigations into deviations and implementing effective CAPAs. You will work closely with cross-functional teams, fostering collaboration and ensuring regulatory compliance throughout the investigations and CAPA lifecycle.Key Responsibilities:Lead and manage deviations investigations, coordinating cross-functional teams to identify root causes and implement appropriate corrective and preventive actions (CAPAs).Establish investigation plans, ensuring they are executed efficiently and in alignment with established quality standards and regulatory requirements.Oversee the collection and analysis of data related to deviations, employing statistical methods when necessary.Collaborate with quality control, production, and regulatory affairs teams to assess the impact of deviations on product quality and safety.Ensure timely initiation, documentation, and closure of deviation investigations and CAPAs, adhering to internal procedures and regulatory guidelines.Generate comprehensive investigation reports and CAPA plans, communicating findings and actions to relevant stakeholders.Monitor and track CAPA effectiveness, performing trend analysis to identify recurring issues and proposing improvements to prevent recurrence.Participate in risk assessments and root cause analyses, driving continuous improvement initiatives.Ensure timely completion of CAPA tasks by providing guidance, support, and motivation to team members.Prepare documentation and reports for audits and regulatory inspections related to deviations and CAPAs.Stay updated with industry regulations, guidelines, and best practices related to deviations, investigations, and CAPAs.Qualifications:Bachelor's degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related field.7+ years of experience in quality assurance, regulatory affairs, or related roles within the pharmaceutical manufacturing industry.Strong knowledge of cGMP regulations, ICH guidelines, and industry best practices.Experience in managing deviations investigations and implementing CAPAs.Proven experience as a QA Lead on a Deviation team.Proficiency in conducting root cause analysis and using statistical tools for data analysis.Excellent written and verbal communication skills.Detail-oriented with strong analytical and problem-solving abilities.Ability to work collaboratively in cross-functional teams.Strong organizational skills and ability to manage multiple tasks simultaneously.
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Job DetailsPharma Manufacturing/Engineering QA Lead, Deviation InvestigationsHarmans, MDPosted: 8/13/2024Job ID#: 1613Job Category: Pharma Manufacturing/EngineeringDuration: 4 monthsShift: 1Positions Available: 5 As the QA Project Manager for Deviations and CAPA Investigations, you will play a pivotal role in ensuring the integrity of our pharmaceutical manufacturing processes by leading and managing investigations into deviations and implementing effective CAPAs. You will work closely with cross-functional teams, fostering collaboration and ensuring regulatory compliance throughout the investigations and CAPA lifecycle.Key Responsibilities:Lead and manage deviations investigations, coordinating cross-functional teams to identify root causes and implement appropriate corrective and preventive actions (CAPAs).Establish investigation plans, ensuring they are executed efficiently and in alignment with established quality standards and regulatory requirements.Oversee the collection and analysis of data related to deviations, employing statistical methods when necessary.Collaborate with quality control, production, and regulatory affairs teams to assess the impact of deviations on product quality and safety.Ensure timely initiation, documentation, and closure of deviation investigations and CAPAs, adhering to internal procedures and regulatory guidelines.Generate comprehensive investigation reports and CAPA plans, communicating findings and actions to relevant stakeholders.Monitor and track CAPA effectiveness, performing trend analysis to identify recurring issues and proposing improvements to prevent recurrence.Participate in risk assessments and root cause analyses, driving continuous improvement initiatives.Ensure timely completion of CAPA tasks by providing guidance, support, and motivation to team members.Prepare documentation and reports for audits and regulatory inspections related to deviations and CAPAs.Stay updated with industry regulations, guidelines, and best practices related to deviations, investigations, and CAPAs.Qualifications:Bachelor's degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related field.7+ years of experience in quality assurance, regulatory affairs, or related roles within the pharmaceutical manufacturing industry.Strong knowledge of cGMP regulations, ICH guidelines, and industry best practices.Experience in managing deviations investigations and implementing CAPAs.Proven experience as a QA Lead on a Deviation team.Proficiency in conducting root cause analysis and using statistical tools for data analysis.Excellent written and verbal communication skills.Detail-oriented with strong analytical and problem-solving abilities.Ability to work collaboratively in cross-functional teams.Strong organizational skills and ability to manage multiple tasks simultaneously.
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