Quality Assurance Auditor

4 weeks ago

Hyderabad, India Reqolentquality Labs Full time

A Quality Auditor is responsible for ensuring that all aspects of the Company's Quality

Management System adhere to regulatory standards and established quality guidelines. This

role is crucial for maintaining the integrity of clinical trial data and protecting the safety of

participants.

Key Responsibilities

* Conducting/Host Audits: Perform internal and host external audits. These audits verify

compliance with Good Clinical Practice (GCP) guidelines, Good Documentation Practices

(GDP), company standard operating procedures (SOPs), and other relevant regulations.

Write up an audit report and track findings.

* Quality Management: Evaluate and help maintain the company's quality management

system (QMS). This includes reviewing quality events, incidents, and complaints to identify

root causes and recommend corrective and preventative actions (CAPAs).

* Documentation and Reporting: Prepare detailed audit reports that document findings,

non-conformities, and recommendations for improvement. Present these findings to senior

management and work with various teams to ensure issues are resolved.

* Regulatory Compliance: Stay up to date with all applicable regulations and guidelines

from bodies like the FDA and the International Council for Harmonisation of Technical

Requirements for Pharmaceuticals for Human Use (ICH). Ensure that these regulatory

requirements are communicated and implemented across the organization.

* Training: Ensure training compliance of quality assurance procedures, GXP guidelines

(such as GCP), and the importance of a quality-focused approach.

Required Skills and Qualifications:

* Education and Experience: A bachelor's degree in a relevant field (e.g., life sciences, or

information technology) or equivalent audit experience. The candidate should possess

working knowledge of US FDA Good Clinical Practices (GCP), Internal Conference of

Harmonization (ICH), Electronic Records; Electronic Signatures (21 CFR part 11) and EU

Annex 11, GDPR, or GAMP 5.

* Analytical Skills: Strong analytical and problem-solving abilities are vital for identifying

discrepancies, evaluating data, and drawing logical conclusions from audit findings.

Attention to Detail: The role demands a meticulous and detail-oriented approach to

reviewing documents, data, and processes.

* Communication: Excellent written and verbal communication skills are necessary to

clearly articulate audit findings and work collaboratively with diverse teams and

stakeholders.

* Knowledge of Regulations: A thorough understanding of GCP, ICH guidelines, and other

relevant clinical trial regulations are a fundamental requirement.

* Certifications: Certifications from professional bodies, such as the American Society for

Quality (ASQ), can be advantageous.

If this role excites you, apply now by sending your resume to with the subject line " Quality Auditor "

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