Quality Associate_16 months contract

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!

Position Description:As the support quality contact for the Elanco Korea Quality organization, the QUALITY ASSOCIATE advises, reports, consults and escalates quality matters relating to Elanco products distributed in Korea, to the Quality Director ANZ and Korea, APAC Affiliate Senior Quality Director and appropriate affiliate management when needed.Functions, Duties, Tasks:CORE JOB TASKS

• Support product quality related matters and collaborate in any local action to be taken as a result of that (i.e. returns, recalls)
• Implement product quality systems and Quality Manual in the Marketing affiliate.
• Assist Quality Director ANZ and Korea and APAC Affiliate Senior Quality Director, in assuring that all operations of the affiliate comply with the Affiliate Quality Manual, applicable company quality standards and local regulations.
• Support the assessment of vendors using a risk based approach.
• Create and revise Quality agreements for vendors
• Support the annual self-inspection program.
• Perform batch dispositions as per internal requirements and local regulations

SPECIFIC AREAS OF ACCOUNTABILITY / RESPONSIBILITY

• Quality Management
• Ensure affiliate compliance with Good Warehousing practices for finished products.
• Support the annual management review process.
• Ensure Notification to Management within one day of identification.
• Halt, hold or quarantine product status as required.

• Quality Systems

Batch Release

• Perform batch disposition in compliance with market authorizations and local regulations.
• Support the confirmatory testing process

Change and Event Management

• Assist with management of the change control and deviation system.
• Maintain local procedures which reflect local regulations (where required) and corresponding global quality standards.
• Create or review relevant quality related documents.
• Ensure record retention as per appropriate record retention periods
• Review testing methods used in dossier submissions to confirm compliance with local Pharmacopeia and capability of local laboratories.

Personnel Qualifications

• Review and approve GMP training material generated by the local affiliate.
• Perform GMP training or equivalent (as required).
• Ensures training records by the local affiliate are documented

Auditing and Inspections

• Support the self inspection program to maintain a state of inspection readiness at the affiliate.
• Assess vendors using a risk based approach
• Support agency inspections and internal Corporate audits as needed.

Adverse Events and Product Complaints

• Ensure a process is in place to report adverse events and product complaints as per Elanco Quality standard and local regulations
• Ensure timely response to customers if necessary
• Escalate serious quality issues e.g. counterfeit, tampering, potential recalls to the Quality Director ANZ and Korea and APAC Affiliate Senior Quality Director.

Recalls

• Support the recall process when required
• Perform a recall simulation as per requirements.

Product Safety Assessment

• Consult with the Quality Director ANZ and Korea and APAC Affiliate Senior Quality Director on the need for a Product Safety assessment.

Materials Management

• Ensure a system is in place to manage the handling, accountability and traceability of inventory including free goods in accordance with local regulations and label storage conditions
• Request approval of returns as per internal requirements.
• Review product donations for compliance to applicable quality standards, local procedures and regulations

Distribution of Finished Products

• Ensure product shipped from one marketing affiliate to another meets the marketing authorization of receiving country.
• Consult on operating temperature and humidity (where applicable) ranges for storage areas
• Ensure inventory cycle counts are performed annually.
• Investigate significant confirmed cycle count discrepancies using the deviation process. Consult with the Quality Director ANZ and Korea and APAC Affiliate Senior Quality Director and gain approval on adjustments outside of accepted tolerances

Packaging and Labeling

• Prepare appropriate labeling documentation for approval as per internal requirements
• Provide quality oversight of local repackaging operations

• Environment Health and Safely
• Adhere to all safe working procedures in accordance with instructions
• Take reasonable care of self and others.

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

• PC Skills – Microsoft; Word, Excel, and Outlook
• Analytical/investigational skills
• Inventory management knowledge highly regarded.

Attributes:

• Attention to detail
• Customer Focus
• Excellent interpersonal and communication (written and oral) skills
• Strong organization and planning skills
• Ability to prioritize and manage competing tasks and timelines
• Teamwork skills

Experience:               0-2 years in a GMP environment.Qualifications:           

• Tertiary qualifications in Science or related field
• Registered Pharmacist

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