At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Location:

Elanco Poland Sp. z o.o. office, Rondo Daszynskiego 2B, 00-843 Warsaw, Elanco Poland Warehouse, 96-320 Mszczonów, Logistyki 3, Poland

Legal basis:

Acting as the Responsible Person in the Pharmaceutical Wholesale of Veterinary Medicinal Products Elanco Poland in accordance with:

• Polish legislation - Pharmaceutical Act of 6 Sept 2001 (OJ. 2001 No 126 pos. 1381)
• COMMISSION IMPLEMENTING REGULATION (EU) 2021/1248 of July 29, 2021 on good distribution practice measures for veterinary medicinal products pursuant to Regulation (EU) 2019/6 of the European Parliament and of the Council
• Local and global company policies

Functions, responsibilities, tasks:

• Ensure that a quality system is in place and applied;
• Focus management of activities covered by the permits and on the reliability and quality of records;
• Ensure that initial and continuous training programs are implemented and maintained;
• Coordinate and promptly perform any recall operations for veterinary medicinal products
• Ensure that relevant customer complaints are dealt with effectively;
• Ensure that suppliers and customers are approved;
• Approve any subcontracted activities which may impact on GDP;
• Ensure that self-inspections are performed at appropriate regular intervals following a pre-arranged program and necessary corrective measures – CAPAs, are put in place
• Keep appropriate records of delegated duties
• Decide on the final disposition of returned, rejected, recalled or falsified veterinary medicinal products;
• Approve returns to stock for sale;
• Ensure that any additional requirements imposed on certain veterinary medicinal products by national law are adhered to;
• Ensure the documentation of deviations and decide on appropriate CAPA to correct deviations and avoid their reoccurrence, and monitoring of the effectiveness of CAPA;
• Responsibility for the execution and implementation of HACCP in the warehouse;
• GMP+: accountable for the completion & accuracy of GMP+ quality tasks, including but not limited to HACC team member, maintenance of quality manual, RASCI matrix, annual self-inspection and annual mock recall. Point of contact for annual audits;
• All other responsibilities under the GDP and to ensure compliance with Polish Law and Elanco Procedures;
• To compete any quality/quality management system (QMS) related task not only related to warehouse management.
• Perform any other duties or serve in such other capacity as may be determined by Company management.
• Deputy RP acts in its capacity in full cooperation with RP and providing RP with full support

AUTHORITY:

The Deputy Responsible Person is personally responsible for the fulfillment of his/her duties.

Deputy Responsible person acts as Responsible Person during its absence and in such case shall make independent decisions at the level of Elanco Wholesale within the framework of his assigned authority under the GDP and the Pharmaceutical Law.

Minimum Qualification (education, experience and/or training, required certifications):

• Master degree in pharmacy, or veterinary medicine;
• Relevant experience and meeting requirements according to Art. 84 of Pharmaceutical Act of 6 Sept 2001 (OJ. 2001 No 126 pos. 1381) to become accredited as a Responsible Person in Poland

Additional Preferences:

• Effective communications (written/verbal)
• Ability to operate computer systems and knowledge of MS Office
• Attention to detail and systematic work
• Organizational skills
• Accuracy, reliability

Other Information:

Fluent in Polish and English (written & verbal)

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status