Main Purpose of the Position:
As the Quality Management contact for the Elanco (Thailand) advises, decides reports, consults and escalates quality matters relating to
Elanco products distributed in Thailand, Cambodia, Laos & Myanmar, to the appropriate affiliate management, Head of Quality ASEAN India and Bangladesh, APAC Affiliate Quality Director and Corporate management when needed. Head of Quality ASEAN India and Bangladesh
and APAC Affiliate Quality Director, here-in will be referred to as Regional Quality Leadership.
Functions, Duties, Tasks:
CORE JOB TASKS
- Be responsible for product quality related matters, escalate any local product quality related issue to the Regional Quality Leadership 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 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 Suppliers, GMP Service Providers and Collaborations
- Revise/approve Quality agreement covering affiliate process for Suppliers, GMP Service Providers and Collaborations
- 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
- Ensure Affiliate compliance with Good Manufacturing Practices (cGMP) and Good Warehousing practices. Also ensure affiliate compliance with all relevant local
- Partake in a governance forums for oversight of product quality, quality systems and quality compliance across the site.
- Report monthly metrics
- Ensure an annual management review is conducted which includes trend reviews
- Ensure Notification to Management is within one day of identification.
- Halt, hold or quarantine product status as required.
- Ensure products received comply with the market authorization requirements, by having a process in place for quality disposition of product, approval and rejection
- Ensure a formal decision making process exists for the redistribution of returns and disposal of any returned, rejected, recalled and counterfeit product.
- Request in consultation with Regional Quality Leadership, approval from the Global Quality Leader of the decision making process for redistribution of recalled
and counterfeit product.
Change and Deviation Management
- Create or review/approve, execute and close change controls that may affect the quality attributes of the product. Assist with management of the change control
- Create or review/approve (observations and non-critical) 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.
- Maintain local procedures which reflect local regulations (where required) and corresponding global quality standards.
- Create or review/approve relevant quality related documents.
- Ensure record retention of documentation as per appropriate record retention period.
- Maintain Quality job descriptions and CVs by reviewing as per global requirements
- Ensure that affiliate management document the review of job descriptions and individual training plans every two years, for accuracy, completeness and appropriateness
- Review Quality Management System training material generated by the local affiliate and ensure training records are documented.
- Development and execute Quality plans to ensure regulatory compliance and commitments are met as per due dates.
- 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 date.
Auditing and assessment
- Conduct self-assessments of quality systems at least annually, to maintain a state of inspection readiness at the Affiliate.
- Ensure assessment of Suppliers, GMP Service Providers and Collaborations where applicable according to a risk based approach
- 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 or review written responses to EGQCA audits by consulting with the Head of Quality ASEAN India and Bangladesh.
- Prepare or review written responses to regulatory agency inspections by consulting with Regional Quality Leadership, 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 Regional Quality Management
Regulatory Interactions with Government Agencies
- Document in agreement with the Regional Quality Leadership, any potential regulatory reportable event as a result of a product defect. Ensure adherence to reporting
- 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 non-routine requests for samples and communications of potential restriction on product supply to management and regulatory agencies.
- Ensure communications to regulatory agencies on a product quality related matter are aligned internally with Regional and Global Quality Leadership.
Adverse Events and Product Complaints
- Ensure a process is in place to report adverse events and product complaints as per internal standards 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 Regional and Global Quality Leadership.
- Liaise with Corporate Anti Counterfeit Issue Management Team on all counterfeit or tampered products complaints reports.
- Provide quality oversight of call centers to ensure the quality system is maintained in a complaint way and reporting requirements are met.
Responsible Complaint Person (RCP) – Back Up
- Maintain general knowledge of product complaint system at Elanco
- Ensure process in place to coordinate complaint sample returns, if required
- Ensure product complaint reporting and investigation meets local regulatory requirements
- Ensure compliance to local Quality Agreements
- Ensure timely response to customer, if required
- Represent product complaint in Marketing affiliate inspection as needed
- Ensure immediate reporting of a significant safety or quality issues are conducted in consultation with Regional Quality Leadership.
- Ensure the recall process is executed, including recall recommendation, report, implementation and closure.
- Ensure a recall simulation is performed as per internal requirements.
Product Safety Assessment (PSA)
- Determine which deviations or complaints affect customer or animal safety
- Consult with Regional and Global Quality Leadership on the need for a Product Safety assessment.
- Use validated global computer systems that support GMP operations
- Ensure GMP records that are non-Electronic Signatory (ES) compliant contain wet signatures.
- Ensure a system is in place to manage the handling, accountability and traceability of inventory including sales representative samples in accordance with local
regulations and label storage conditions.
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 as per internal requirements.
- Ensure significant confirmed cycle count discrepancies are investigated using the deviation process. Consult with Regional Quality Leadership and gain approval
on adjustments outside of accepted tolerances.
- Review product donations for compliance to applicable quality standards, local procedures and regulations
- Approve Quality Agreements for co-promotions, distribution, brand divestments and non-trademark supply agreements.
- Review Quality Agreements between internal sites and groups
- Ensure Quality Agreements between Thailand Affiliate, Suppliers, GMP Service Providers and collaborations are created, approved and maintained.
Packaging and Labeling
- Ensure that appropriate labeling review and approval processes are in place.
- Approve appropriate repackaging documentation
- Provide quality oversight of local repackaging operations and notify to the original packaging site as required.
Personnel Development and Management
- Supervise and prioritize the work of the Quality department
- Personal and technical development of direct reports
- Implement performance management for direct reports
- Provide coaching and feedback to direct reports and business partners
- Implement succession planning by building a talent pipeline
- Utilize recognition programs appropriately
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.
- Supervisory skills
- 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
- At least 8-10 years in Quality experience and GMP environment.
- Experience in managing a team is preferred
Tertiary qualifications in Science or related field
Fluent in English both writhing and spoken for Business Communication
Willing to travel in Oversea (APAC)
Ability to work in under pressure environment Result oriented, and good selling skills Strong communication and interpersonal skills, and presentation skills.
Demonstrated leadership, adaptability, dealing with ambiguity.
Team player with high degree of customer focus (Active listening)
Strong self-management and organizational skills.
Ability to work independently and influence teams without authority to deliver on expectations