Senior Associate, Quality Assurance

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!

What will you be doing?

As the central quality contact for the Elanco Marketing Affiliate organizations (Japan), the Quality Senior Associate advises, decides reports, consults and escalates quality matters relating to Elanco products distributed in Japan, to the affiliate management, Head of Quality Japan, Senior Director APAC Affiliate Quality or Corporate management when needed.

What we offer:

• A flexible working environment that will let you do your best work possible. 
• Continuous improvement opportunities: a key goal for us is to help good people get even better.
• We are passionate about practicing our core values of integrity, excellence, and respect for people in everything that we do.

You’ll need the following:  

Qualifications & Experience:

• Pharmacist Degree (Mandatory)
• English fluent communication skill (Mandatory; TOEIC over 750 preferred)
• PC Skills (Mandatory) – 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
• Self-managed
• Teamwork skills

Experience:

• At least 2-5 years Quality experience in a GMP/GQP environment (preferred).

Qualifications:

• Tertiary qualifications in Science or related field

Additional Preferences:

• SAP inventory system knowledge
• Pharmaceutical or Animal Health industry experience

As Sr. Associate, you will do the following:

Core Job Tasks

• Warehouse oversight for feed/feed additive labelling, completion of license related documentation and monthly license check for distributed products.
• Purchase order and payment requests for national assay and narasin testing
• Management of record retention for Quality
• Be responsible for product quality related matters, escalate any local product quality related issue to the Head of Quality Japan, Senior Director APAC Affiliate Quality and the Affiliate management, and collaborate in any local action to be taken as a result of that (i.e. recall, counterfeit etc.)
• Implement and monitor product quality systems and Affiliate Quality Manual in the Marketing Affiliate.
• Assist affiliate management and Head of Quality Japan in assuring that all operations of the affiliate comply with the Affiliate Quality Manual and other applicable company quality standards, GQP and local regulations.
• Execute the assessment plan for GMP Service Providers and collaborations.
• Create and revise Quality agreement covering affiliate process for GMP service providers.
• Demonstrate continuous improvement and minimize risk by a routine self-assessment, corrective and preventative actions (CAPA), and use of a Quality Plan.
• Ensure an affiliate training program for employees with quality duties and responsibilities is in place.
• Be responsible for product complaints related matters. Investigate product complaints and respond to customers as needed
• Warehouse management
• Management of record retention for Quality
• Actual operation for the National Assay (approximately 2 times per month with sampling, labeling activities with agency officers and operators in warehouse)

SPECIFIC AREAS OF ACCOUNTABILITY / RESPONSIBILITY

Quality Management

• Ensure Affiliate compliance with Good Manufacturing Practices (cGMP), Good Warehousing practices, GQP and good Local testing practices for finished products.
• Also ensure affiliate compliance with all relevant local regulations.
• Support quarterly quality reviews which includes affiliate specific metrics.
• Support the annual management review.
• Prepare Notification to Management within one day of identification.
• Halt, hold or quarantine product status as required.

Quality Systems

Batch Release

• Ensure products received comply with the Japanese market authorization, by having a process in place for quality disposition of product, approval and rejection of batches.
• Request in consultation with the Head of Quality Japan, APAC Affiliate Quality Director, approval from the Global Quality Leader of the decision making process for redistribution of any rejected, recalled and counterfeit product
• In conjunction with the Head of Quality Japan, ensure a formal decision making process exists for the disposal or redistribution of any returned, rejected, recalled and counterfeit product.

Change and Deviation Management

• Create, execute and close change controls that may affect the quality attributes of the product. Assist with management of the change control system.
• Create and resolve deviation (events) from normal procedures that could potentially impact safety, identity, strength and quality of the product. Ensure deviation completion is within requirements and corrective and preventative actions are completed by target date.

Documentation

• Maintain local procedures where required by local regulations and corresponding global quality standards.
• Create or review/approve relevant quality related documents.
• Ensure record retention of documentation as per appropriate record retention period.

Personnel Qualifications

• Maintain a job description and job profile that describes the quality duties and review it every two years.
• Ensure that affiliate management document the review of job descriptions and individual training plans every two years, for accuracy, completeness and appropriateness.
• Create and review GMP, GQP training material generated by the local affiliate and ensure training records are documented.

Quality Plan

• Development and execute the Quality plan to correct and prevent recurrence of significant quality problems from audits, self-inspections, deviations, recalls, product complaints or significant changes.
• Ensure compliance to the Affiliate Quality Manuals, other applicable company quality standards, GQP, GMP and relevant local regulations by completing quality system maintenance activities by target due date.
• Adhere to and meet Quality plan actions target due dates.

Auditing and assessment

• Conduct self-assessments of quality systems at least annually, to maintain a state of inspection readiness at the Affiliate.
• Assess GMP suppliers and service providers where applicable according to an approved plan.
• Facilitate and co-ordinate Regulatory Agency inspections, EGQCA audits of the affiliate and service providers. Support the affiliate with the audit readiness plan. Take daily notes and report the daily audit activities to the affiliate Lead Team.
• Prepare written responses to EGQCA audits by consulting with the Head of Quality Japan and Senior Director APAC Affiliate Quality. Prepare written responses to regulatory agency inspections by consulting with the Head of Quality Japan, Senior Director APAC Affiliate Quality, Global Senior Quality Director and Director of EGQCA. Ensure timely responses and execution of actions by target due dates.
• Review and consult on all new business deals that require quality operations with the Head of Quality Japan and Senior Director APAC Affiliate Quality.
• Create and review Quality Agreements for co-promotions, distribution, brand divestments and non-trademark supply agreements.

Regulatory Interactions with Government Agencies

• Document in agreement with the Head of Quality Japan and Senior Director APAC Affiliate Quality, any potential regulatory reportable event as a result of a product defect. Ensure adherence to reporting timelines.
• Provide information required for NTMs such as but not limited to site notification of a regulatory inspection (announced and unannounced), requests for regulatory responses to product quality related matters, agency requests for samples (raw materials, intermediates, active pharmaceutical ingredient or drug product) and communications of potential restriction on product supply to management and regulatory agencies.
• Participate in communications to the regulatory agencies on a product quality related matter.

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 a process is in place to manage product complaints, data collection, assessment, action notifications and closure within required timelines, trending and record retention.
• Investigate product complaints as required to ensure closure within required timelines.
• Escalate serious quality issues e.g. counterfeit, tampering, potential recalls to the Head of Quality Japan and Senior Director APAC Affiliate Quality.
• Liaise with Global Product Security on counterfeit or tampered products complaint reports as needed.

Back up RCP or RCP

• Maintain general knowledge of product complaint process at Elanco
• Maintain visibility of Product Complaints reported in the Marketing Affiliate
• Ensure a process is in place to coordinate timely complaint sample returns in the event a product complaint investigation is necessary
• Ensure compliance of any local requirements related to product complaints in the affiliate not manages globally
• Ensure Product Complaint investigations meet local requirements
• Ensure Compliance with local quality agreements
• Ensure timely response to customers if necessary
• Represent product complaints in Marketing Affiliate inspections as needed

Recalls

• Ensure immediate reporting of a significant safety issue is conducted in conjunction with the Head of Quality Japan and Senior Director APAC Affiliate Quality.
• Participate in the recall process when required, including recall recommendation, report, implementation and closure.
• Perform a recall simulation as per requirements.

Product Safety Assessments (PSA)

• Determine which deviations or complaints affect customer or animal safety
• Consult with the Head of Quality Japan and Senior Director APAC Affiliate Quality on the need for a Product Safety assessment.

Computer Systems

• Ensure computer systems used to either execute or support GMP operations are validated.
• Assist in ensuring there is a process for managing GMP records from systems that are non-Electronic Signatory (ES) compliant.

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 in consultation with the Head of Quality Japan and Senior Director APAC Affiliate Quality, approval from the Global Quality Leader of the decision making process for redistribution of any rejected, recalled and counterfeit product
• Follow the internal requirements disposal or redistribution of any returned, rejected, recalled and counterfeit product.
• Ensure Quality Agreements are in place between Elanco sites
• 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.
• Investigate significant confirmed cycle count discrepancies using the deviation process. Consult with the Head of Quality Japan and gain approval on adjustments outside of accepted tolerances.

Packaging and Labelling

• Ensure that appropriate labeling review and approval processes are in place.
• Prepare appropriate repackaging documentation for approval by Head of Quality Japan.
• Provide quality oversight of local repackaging operations and notify to the original packaging site as required.

Environment Health and Safely

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

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