QA Lead, Deviation Investigations - Raland Compliance Partners

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.