GMP Auditor

There is a vacancy for a GMP Auditor in a foreign company

Main responsibilities:

• Conduct independent appraisals of quality and compliance systems within technically advanced manufacturing settings.

• Performs complex and demanding domestic and international (subject to experience) audits of suppliers of chemicals, packaging components, and finished drug products, or contracted services. Audits are conducted in accordance with cGMP´s, ISO Standards, IPEC, ICH Q7A and company procedures.

• Plans, coordinates and conducts scheduled or unscheduled cGMP audits of complex internal Company Operational departments to ensure compliance to CGMP´s and Company standards.

• Provide clear and scientifically/technically justified interpretations and support for any audit findings and proposed corrective and preventive actions.

• Liaise directly with local Company and/or regional and global senior management, where necessary, to ensure issues are understood and proposed actions are acceptable.

• Interpret and apply cGMP regulations and expectations.

• Proven written and oral skills with experience working in cross-cultural settings

• Initiate and maintain close contacts with regulatory agencies and/or industry/professional organizations to keep aware of trends and initiatives in quality assurance, GMP compliance, and inspections.

• Develop and interpret audits findings across the scope of the Global Quality Audit (GQA) in order to communicate trends and provide recommendations to address such developing trends in a proactive manner.

• While maintaining independence, work closely with other QA colleagues to assure common understanding of developing interpretations of cGMP

Working environment:

· The level of compensation is discussed individually

· Annual bonus

· Medical insurance

· Corporate mobile communication

· 3 days day-off