Quality Assurance Auditor II, GMP
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
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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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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