Quality Auditor - II - FSR Level - P2

Proclinical is seeking a Quality Auditor to join a team focused on ensuring compliance with regulatory standards and internal procedures within the pharmaceutical industry. This role involves conducting audits, reviewing documentation, and collaborating with teams to address findings. If you have a strong understanding of cGMP regulations and enjoy working in a detail-oriented environment, this could be a great opportunity for you.

Responsibilities:

• Conduct routine audits of data, procedures, equipment, systems (including computer systems), and facilities to ensure compliance with SOPs, GMPs, and global regulations.
• Review and approve production and analytical documentation related to the release of API, safety assessments, or clinical supply lots (bulk and packaged) to ensure regulatory conformance.
• Communicate and resolve audit findings with relevant teams and stakeholders.
• Perform audits or inspections of assigned areas or systems, either independently or as part of a team, to assess compliance with regulatory and company standards.
• Issue reports summarizing deficiencies and collaborate with teams to implement corrective actions.
• Notify appropriate management of inspection results and follow up on remedial actions.

Key Skills and Requirements:

• Experience in the pharmaceutical-chemical industry or a government drug-regulatory agency.
• Strong working knowledge of cGMP regulations.
• Effective oral and written communication skills, along with strong interpersonal abilities.
• Ability to work independently or as part of a team with moderate supervision.
• Skilled in identifying compliance gaps and recommending actionable solutions.

If you are having difficulty in applying or if you have any questions, please contact Molly Colclough at .

Apply Now:

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Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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