Quality Assurance Auditor Ii, GMP

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 clinical research leaders, we seek Quality Assurance Auditor II (GMP) to join their innovative and collaborative team.

Quality Assurance Auditor II (GMP) will assume responsibility for quality assurance activities to support our Good Manufacturing Practice (GMP) Pharmacy audits.

Quality Assurance Auditor II - GMP

Location: Home-based or Office-based - Bulgaria, Poland

Duties and Responsibilities:

• Perform contracted, routine and complex internal audits according to client expectations and/or the company's SOPs. The exciting potential to function as a lead auditor on an audit team. Ensure planning, conduct, reporting, responses and follow up actions are managed according to the company's internal procedures.

• You will review and assess non-conformities and other pertinent GMP documentation as per recognized GMP standards of EMEA/FDA during your duties as a GMP Auditor.

• Further aspects of this challenging role include the interpretation of regulations and guidance documents governing GMP and applying this within day-to-day structures for the company staff and client representatives.

• You will be additionally responsible for facilitating client audits and regulatory inspections at the aforementioned locations.

• Work closely with our QPs/Pharmacists regarding GMP within the company or sub-contracted sites.

Qualifications, Skills & Experience:

• Life science degree at Bachelor or Masters level from an accredited institution.

• 2+ years of previous experience working as a GMP Auditor.

• Fluency in English.

• You are a self-motivated, focused individual with excellent communication skills. A strong personality who functions well either as a team member or sole contributor.

• Technically competent in all aspects of auditing and GMP manufacture.

• Experience of facilitating/hosting audits and Inspections.

• A self-starter with drive and enthusiasm.

• Travel: up to 45% of the time (approximately 1-2 travels per month to a vendor facility site).

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.

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As KCR became part of the ICON group, your personal data will be shared with ICON and processed in accordance with privacy notice: https://www.iconplc.com/privacy/job-applicants

If you want your candidacy to be considered also for future recruitments, please send us an additional consent: “I agree to the processing of my personal data for any future recruitments conducted by ICON”. Such consent may be placed in your CV or electronic correspondence addressed to us. You can withdraw your consent at any time. Withdrawal of consent does not affect the legality of the processing carried out prior to its withdrawal.

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.