Assist lead auditors/audit liaisons in conducting, hosting and reporting quality assurance audits by performing specific audit tasks under the direct supervision of more senior QA staff.
• Assist in conducting quality assurance audits within budget and established timelines by scheduling, conducting, reporting, and closing audits as directed by the lead auditor. Activities may include contacting auditees to agree on audit dates, making appropriate entries in QA database , performing data reviews, file audits as directed
• Entering and categorizing audit/Inspection findings in eQMS,
• Soliciting follow-up information and closing audits/inspection findings in the QA database.
• Review and approval of Corrective and Preventative Action (CAPA) and Effectiveness Check (EC) plans
• Support Investigators derogatory status management in the database, prepare and release guidance document with compliance information and maintain the QA repository with compliance information for investigators with derogatory status
• Assist in hosting customer audits, mock regulatory inspections, and regulatory facility inspections by acting as a scribe. Reviewing documents, identifying and calling operational staff to answer related questions. Performing required administrative duties including tracking of documents reviewed, scheduling audit team members for interviews and coping and stamping documents for release to the auditors/inspectors.
• Obtain a fundamental knowledge of current relevant GXP regulations, guidelines, and related auditing techniques.
• Provide QA consultancy where possible
• Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle.
• Bachelor’s Degree
• 1 year Quality Assurance experience in pharmaceutical, technical, or related area, including GXP and/or Quality Assurance experience. Equivalent combination of education, training and experience.
• Knowledge of word-processing, spreadsheet, and database applications..
• Considerable knowledge of GXP regulations and quality assurance auditing techniques..
• Strong interpersonal skills.. Excellent problem solving skills..
• Effective organization, communication, and team orientation skills..
• Ability to initiate assigned tasks and to work independently..
• Ability to manage multiple projects..
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.