Pharmaceutical Deviation Investigator
3 weeks ago
Raland Compliance Partners, LLC is seeking a highly skilled Pharmaceutical Deviation Investigator to join our team. As a key member of our quality assurance department, you will be responsible for investigating and documenting deviations from established procedures, leading deviation investigations to identify root causes, and implementing effective corrective and preventive actions (CAPAs) to prevent recurrence.
Key Responsibilities- Investigation and Documentation: Collaborate with production, quality control, and regulatory affairs teams to investigate and document deviations from established procedures.
- Root Cause Analysis and CAPAs: Lead deviation investigations to identify root causes and implement effective CAPAs to prevent recurrence.
- Quality and Regulatory Compliance: Ensure timely initiation, documentation, and closure of deviation investigations, following internal procedures and regulatory guidelines.
- Reporting and Communication: Generate deviation reports and communicate findings to relevant stakeholders, including management and regulatory agencies when necessary.
- Risk Assessment and Mitigation: Participate in risk assessments related to deviations and recommend appropriate mitigation strategies.
- Continuous Improvement: Collaborate with manufacturing and quality teams to ensure that deviations are properly tracked, trended, and addressed, and contribute to the development and implementation of continuous improvement initiatives to reduce the occurrence of deviations.
- Education: Bachelor's degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related field.
- Experience: 2 years of experience in quality assurance, quality control, or regulatory affairs within the pharmaceutical manufacturing industry.
- Knowledge and Skills: In-depth knowledge of cGMP regulations, ICH guidelines, and industry best practices, strong understanding of pharmaceutical manufacturing processes and quality systems, experience in conducting investigations, root cause analysis, and implementing CAPAs, excellent written and verbal communication skills, detail-oriented with strong analytical and problem-solving abilities, proficiency in using quality management systems and documentation tools, and ability to work collaboratively in cross-functional teams.
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Pharmaceutical Deviation Investigator
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Dunkirk, New York, United States Raland Compliance Partners, LLC Full timeJob Title: Pharmaceutical Deviation InvestigatorRaland Compliance Partners, LLC is seeking a highly skilled Pharmaceutical Deviation Investigator to join our team. As a key member of our quality assurance department, you will be responsible for investigating and documenting deviations from established procedures, leading deviation investigations to identify...
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