As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better.
Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life.
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Position Description : As the central Quality contact for the Elanco Marketing Affiliate organization, the QUALITY MANAGER advises, decides reports, consults and escalates quality matters relating to Elanco products distributed in Vietnam to the appropriate affiliate management, ASEAN Quality Director, APAC Senior Director Affiliate Quality or Corporate management when needed.
Functions, Duties, Tasks : CORE JOB TASKS
Be responsible for product quality related matters, escalate any local product quality related issue to the ASEAN Quality Director, APAC Senior Director Affiliate 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 Quality Manual in the Marketing affiliate.
Assist affiliate management, ASEAN Quality Director and APAC Senior Director Affiliate in assuring that all operations of the affiliate comply with the Affiliate Quality Manual and other applicable company quality standards and local regulations.
Execute the assessment plan for GMP Service Providers.
Create and revise Quality agreements covering affiliate processes 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.
SPECIFIC AREAS OF ACCOUNTABILITY / RESPONSIBILITY Quality Management
Ensure affiliate compliance with Good Manufacturing Practices (cGMP) and Good Warehousing practices for finished products.
Also ensure affiliate compliance with all relevant local regulations.
Support Quarterly Quality Reviews
Ensure an annual management review is conducted.
Ensure 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 market authorization, by approving / rejecting batches. Change and Event 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 deviations (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 which reflect local regulations (where required) and corresponding global quality standards.
Create or review relevant quality related documents.
Ensure record retention of documentation as per appropriate record retention period. Personnel Qualifications
Maintain a job description and carrier profile that describes the quality duties and review it every two years.
Review, and approve GMP, training material generated by the local affiliate and ensure training records are documented Quality Plan
Develop and execute the Quality plan as per internal requirements and local regulations as applicable
Ensure compliance to the Affiliate Quality Manual, other applicable company quality standards and relevant local regulations by completing quality system maintenance activities by target due dates
Adhere to and meet Quality plan actions target due dates. Auditing and Inspections
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 ASEAN Quality Director and APAC Senior Director Affiliate.
Prepare written responses to regulatory agency inspections by consulting with the ASEAN Quality Director, APAC Senior Director Affiliate, 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 ASEAN Quality Director and APAC Senior Director Affiliate
Consult with ASEAN Quality Director and APAC Senior Director Affiliate Quality on all Quality Agreements for co-promotions, distribution, brand divestments and non-trademark supply agreements Regulatory Interactions with Government Agencies
Document in agreement with the ASEAN Quality Director and APAC Senior Director Affiliate, 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, closure within required timelines, trending as per internal requirements 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 APAC Senior Director Affiliate.
Liaise with Global Product Security on all counterfeit or tampered products complaint reports 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 such as
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 ASEAN Quality Director and APAC Senior Director Affiliate.
Execute the recall process when required, including recall recommendation, report, implementation and closure.
Perform a recall simulation as per requirements. Health Hazard Evaluation (HHE)
Determine which deviations or complaints affect customer or animal safety.
Consult with the ASEAN Quality Director and APAC Senior Director Affiliate 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 ASEAN Quality Director and APAC Senior Director Affiliate, approval from the Global Quality Leader of the decision making process for redistribution of any rejected, recalled and counterfeit product
In conjunction with the ASEAN Quality Director and APAC Senior Director Affiliate, ensure a formal decision making process exists for the 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
Ensure inventory cycle counts are performed annually.
Investigate significant confirmed cycle count discrepancies using the deviation process.
Consult with the ASEAN Quality Director and gain approval on adjustments outside of accepted tolerances Packaging and Labeling
Ensure that appropriate labeling review and approval processes are in place
Prepare appropriate labeling documentation for approval by ASEAN Quality Director.
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. Minimum Qualification (education, experience and / or training, required certifications) :
PC Skills Microsoft; Word, Excel, and Outlook
Analytical / investigational skills
Inventory management knowledge highly regarded. Experience : At least 2-5 years Quality experience in a GMP environment. Qualifications :
Tertiary qualifications in Science or related field 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