Auditor – Good Clinical Practices – Gcp

Auditor – Good Clinical Practices – Gcp

Requirements

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
• The ability to fluently read, write, understand and communicate in English
• 2 Years of Relevant Experience

Responsibilities

• Plans, conducts, and manages GCP (remote or onsite) and or other type of GXP audits with aunder limited supervision.
• Supports and contributes to the overall audit planning and scheduling process. Ensures assigned audits are tracked appropriately. Submits audit plan change control documentation as needed.
• Ensures audit observations are communicated appropriately to Auditee and Senior Management. Ensures escalation process of critical observations is followed. Prepare and distribute audit reports according to Alcon requirements and timelines.
• Reviews, evaluates and approves proposed corrective and preventative action plans (CAPA) in collaboration with the responsible business partner.
• Provides guidance and advice to clinical teams on GCP related questions.
• Tracks, trends, interprets, and presents GCP compliance data for management metric review meetings and for continuous improvement.
• Supports and prepares teams for regulatory inspections and/ or corporate audits as directed. Enter and track Health Authority inspection information and reports in database.
• Mentors and trains junior auditors. Provide technical guidance, leadership, and coaching of audit related activities. Performs auditor certification process and assessments for new auditors.
• Provides guidance, review, and approval of associated deviations (NCI, & CAPAs). If necessary, lead and support the investigation of deviations and other quality issues detected from any source. Accountable for CAPA follow up and verification activity jointly with Clinical Development.
• Provides QA support to Supplier Evaluation Teams as needed and conducts GXP audits as assigned.
• Stays current on activities in Clinical by reviewing list of ongoing studies and attending Study Review and Project Kick-Off Meetings.
• Supports additional CQA initiatives and other cross-functional duties as assigned.

Preferred Qualifications

• 5 years experience in medical device and/or pharmaceuticals audits
• 3-5 years in GCP auditing role
• Knowledge of ISO 14155, ICH 6, Medical Device EU and FDA regulatory requirements and Declaration of Helsinki.
• Proven GCP audit track record.
• Good Analytical Skills and Judgement
• Advocate for exceptional quality and compliance standards – does not compromise on customer expectations and regulatory requirements