A small pharmaceutical company is recruiting a Quality Compliance Auditor to join their team in Baltimore, Maryland. This is a permanent role.
- This Quality Compliance Auditor position will be responsible for managing internal audit program and vendor audit program for GMP, GDP and GLP compliance, working closely with the operational functions to define the processes and systems to be audited annually.
- This role will manage and maintain the internal audit schedules, ensuring that audits are conducted, corrections are completed and metrics are evaluated and presented to management.
- This position is responsible for quality system functions in accordance with GMPs and related company SOP's, state, federal and local laws applicable.
- This position is part of a highly visible operational Quality Assurance Compliance Team. Is well versed with all relevant company procedures and policies, cGMP and safety and FDA regulations.
- Creates a systematic approach for the conduct of all audits
- Coordinates with GXP operational groups and Quality Systems on developing a holistic Quality Auditing strategy
- Leads internal GMP, GDP and GLP auditing processes; Prepare, Review Audit Reports.
- Leads for-cause audits to address suspected critical audit findings, fraud, or misconduct related to vendors, etc. These complex and highly sensitive audits may involve issues related regulatory violations, controlled substances, and other highly sensitive matters.
- Manage the annual calendar for internal audits and vendor audits and update the master calendar, plans scope and schedules the audit with internal departments, creates audit plan, identifies resources within to conduct the audit, Issues audit observations and report, Tracks resolution of audit findings in approved audit tracking system.,
- Manages area specific SOPs. Report audit metrics to Department Leadership and Quality Leadership
- Responsible for reviewing progress toward closure of audit findings and reporting the progress to appropriate management. Additionally, responsible for performing follow-up on all supplied information in order to perform verification checks on proposed corrective actions.
- Schedules and performs customer requested audits of the quality system to ensure documentation, practices,and procedures are in compliance with SOPs and cGMPs.
- Prepares reports and action items from areas impacted during audit that support or risk the compliance state of the facility.
- Supports readiness of the facility for Regulatory Inspection.
- Assist the Manager of QA Compliance during regulatory agencies inspections such as FDA and/or during internal company audits documenting FDA communications between Site and agency.
- Ensures timely completion of commitments from regulatory agency inspections and partner audits.
Experience and Qualifications:
- Bachelor's degree in a science or related field or equivalent combined education and experience.
- A minimum of five (5) years of relevant pharmaceutical industry experience.
- Extensive experience in Quality auditing and conduct of vendor audits.
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A full job description is available on request.
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