QA Deviation Investigations

Collaborate with production, quality control, and regulatory affairs teams to investigate and document deviations from established procedures.Lead deviation investigations to identify root causes and implement effective corrective and preventive actions (CAPAs) to prevent recurrence.Ensure timely initiation, documentation, and closure of deviation investigations, following internal procedures and regulatory guidelines.Review and assess the impact of deviations on product quality, safety, and regulatory compliance.Generate deviation reports and communicate findings to relevant stakeholders, including management and regulatory agencies when necessary.Participate in risk assessments related to deviations and recommend appropriate mitigation strategies.Collaborate with manufacturing and quality teams to ensure that deviations are properly tracked, trended, and addressed.Contribute to the development and implementation of continuous improvement initiatives to reduce the occurrence of deviations.Stay updated with industry regulations, guidelines, and best practices related to pharmaceutical manufacturing deviations.Provide training and guidance to manufacturing personnel on deviation reporting and investigation processes.Assist in audits and inspections related to deviations by providing documentation and explanations.Job Requirements

Bachelor's degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related field.2 years of experience in quality assurance, quality control, or regulatory affairs within the pharmaceutical manufacturing industry.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.Ability to work collaboratively in cross-functional teams.Strong organizational skills and ability to manage multiple tasks simultaneously.