Senior QA Auditor - Client Audit Management

KCR Placement is a full-service functional sourcing and recruitment provider. We specialize in high-speed and high-quality talent sourcing for the CRO, Pharmaceutical, Biotech and Medical Device industries across Europe. 
Our employees are KCR Placement's most crucial asset. We commit to placing our candidates at the center of all we do and prepare them for long-term career development and success with competitive benefits and vibrant work environment. 
The KCR Placement team is supported by a specialized referral network of expert professionals and is dedicated to providing sourcing services and client support from job requisition to job offer. 

On behalf of our partner, one of the global leaders in clinical research, we are seeking an experienced Senior QA Auditor to join their innovative and collaborative team.

Senior QA Auditor will play a key role in coordinating and supporting external audits, acting as the primary liaison between client auditors and internal teams. The ideal candidate will ensure smooth communication, manage timelines, and oversee the effective resolution of any observations and corrective and preventive actions that arise from the audit process.

Senior QA Auditor - Client Audit Management

Location: Bulgaria or Poland (hybrid/ home-based)

Duties and Responsibilities:

• Leading and supporting external audits of the company including scheduling, preparation and hosting;
• Leading CAPA management for external audits of the company and/or investigator sites, where needed, in order to assure responses are compliant with the company or Sponsor SOP requirements;
• Leading CAPA management for sponsor audits of the company, including liaising with operation teams to ensure timely completion of audit responses, supporting operations to ensure responses are appropriate, including ensuring appropriate corrective and preventative actions are implemented and liaising with the client to deliver responses with in the agreed timelines and respond to any resulting follow-up;
• Leading quality issue investigations, including ensuring appropriate root cause analysis is performed, and adequate corrective and preventative actions are implemented;
• Ensuring CAPAs are formally recorded and reported and actions are documented and followed until resolution;
• Identify and track required effectiveness checks and ensure checks are completed within the required timelines;
• Providing advice and support to the operation teams where needed to ensure CAPA are compliant with GCP and applicable regulatory requirements;
• Supporting other Q&C teams with audits of the company, including conducting audits of the company, investigator sites and/or vendors, when deemed necessary.

Qualifications, Skills & Experience:

• Knowledge/experience in hosting external audits and/or regulatory inspections;
• Knowledge/experience in CAPA management, including performing effective root cause analysis;
• Ability to review and evaluate clinical data/records;
• Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients;
• Detailed understanding of drug development and clinical trial process;
• Good problem resolution skills;
• Good planning and organizational skills with the ability to multi-task and prioritize effectively;
• Ability to work efficiently and independently under pressure;
• Ability and willingness to travel on occasion to accommodate the client;
• Experience of GCP Guidelines and relevant regulations for the conduct of clinical trials would be beneficial.

Benefits:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
• Global Employee Assistance Program
• Life assurance
• Country-specific flexible benefits, including options like gym membership discounts, childcare vouchers, and more.

Learn more about KCR Placement

KCR Placement operates as a full-service recruitment services provider, placing high-quality talents in the CRO, Pharmaceutical, Biotech and Medical Device industries across Europe.

Our Employees are KCR Placement's most crucial asset. We commit to placing our candidates at the center of all we do and setting them up for long-term career development and success. Our Employees receive attractive benefits in compliance with all national regulations. We are proud of providing excellent working conditions and a dynamic work atmosphere.

KCR is an equal opportunity employer. In line with our motto, ‘We see human behind every number,’ KCR is committed to fostering an inclusive culture and maintaining a diverse, safe, and respectful working environment with equitable treatment for all.

We are committed to non-discriminatory practices and provide an equal opportunity for all qualified employees and job applicants within all employment sectors. We believe that in developing a desirable culture of belonging in which diverse perspectives and voices are welcomed and heard, the full potential of employees can be achieved.

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Providing your personal data is voluntary, however, if you do not provide us with the necessary information, we will not be legally allowed to get in touch with you and consider your application. By sending application documents containing your personal data to a wider extent than required by provisions of the applicable laws, you are granting consent for the data to be processed for the purposes of the ongoing recruitment.

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KCR is an equal opportunity employer providing its staff with excellent opportunities to build dynamic, long-term careers.