Description:
The Senior Quality Auditor is a member of the Quality Assurance Team reporting directly to the Sr Manager, Quality Auditing. They conduct internal audits ensuring compliance with all applicable cGMP regulations, processes, systems and provisions of the Quality System. They host and manage regulatory authority and client inspections. They serve as a technical expert within the Quality Auditing department. They are responsible for results in terms of quality system conformance to regulations and Simtra quality policies.
The responsibilities:
Performs internal audits / assessments by collecting and analyzing objective evidence regarding issues and risks. Ensures that audit schedules are produced and communicated in a timely fashion. Plans, schedules, coordinates, supports, and leads detailed audits of facility practices to ensure that policies and procedures comply with worldwide regulatory agencies and Corporate Quality Policy guidelines. This includes review of updated GMP regulations and current FDA and outside of US requirements and incorporation into internal programs, where appropriate.
- Leads/supports Client audits of the facility. Prepares for the audit/assessment activity by researching background information, including previous audit results. Assists in reviewing audit responses. Maintains the assessment file through the process to closure.
- Supports routine GMP and Pre-Approval Inspection regulatory audits. Prepares for audits by coordinating documentation, arranging facility tours, reserving conference rooms, and communicating with facility subject matter experts. Assists in pre- and post- audit communications with Global Quality and regulatory bodies. Interfaces with regulatory inspectors during audits.
- Evaluates corrective and preventive action responses to assessment findings for adequacy, including root cause and timeliness.
- Conducting and confirming follow-up actions on Corporate, Client, Regulatory and Internal site compliance audits. Reports extended corrective actions to management.
- Performs procedure gap assessments to ensure compliance with Global Quality procedures.
- Maintains and makes recommendations for improvement to Quality procedures.
- Performs desktop evaluations of site’s suppliers per Global Quality procedures.
- Considered a Subject Matter Expert for department.
- Mentors other auditors.
- Trains subject matter experts for inspection readiness.
Qualifications:
- Bachelors degree required. Preferably in a science or technical discipline.
- Minimum 5 years experience in the pharmaceutical industry, which should include at least 3 years of auditing experience.
- ASQ and/or RAB auditor accreditation is strongly desired.
- Extensive working knowledge of applicable quality and regulatory standards and regulations.
- Excellent communication skills – both written and oral.
- Work effectively independently and in team environment.
- Must demonstrate sound judgment and analytical skills to enable assessment of risk.
- Expertise in GMP regulations.
- Ability to demonstrate strong organizational skills.
- Good working knowledge of Windows based applications.
- Resourceful, self-reliant, self-motivated and confident.
- Working knowledge of quality software system (e.g. TrackWise, Veeva).
- General knowledge of Lean Six Sigma and other continuous improvement tools.