职位描述
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 China , to the appropriate affiliate management, Senior Region Quality Manager, Regional Quality Leader 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 Senior Region Quality Manager, Regional Quality Leader 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, Senior Region Quality Manager, Regional Quality Leader 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.
? 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
1. 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.
? Conduct quarterly trends (events, complaints, approvals).
? Ensure an annual management review is conducted.
? Ensure Notification to Management within one day of identification.
? Halt, hold or quarantine product status as required.
Batch Release
? Ensure products received comply with the market authorization, by approving/rejecting batches.
? Where QC testing of API (Active Pharmaceutical Ingredient) is a local regulatory requirement, ensure Good Manufacturing Practices (GMP) is followed
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 CV that describes the quality duties and review it every two years.
? Review, and approve GMP, GQP training material generated by the local affiliate and ensure training records are documented
Quality Plan
? Develop 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 Manual, other applicable company quality standards, GQP 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.
Regulatory Interactions with Government Agencies
? Provide information required for reporting to global management 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 and record retention.
? Investigate product complaints as required to ensure closure within required timelines.
? Provide quality oversight of call centers to ensure the quality system is maintained in a compliant way and reporting requirements are met.
? Ensure timely response to customers if necessary
? Represent product complaints in Marketing Affiliate inspections as needed
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
? Ensure Quality approval of promotional items that have a potential to impact the product quality or safety of the customer and/or animal
? Request in consultation with the Senior Region Quality Manager and Regional Quality Leader, approval from the Global Quality Leader of the decision making process for redistribution of any rejected, recalled and counterfeit product
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 Senior Region Quality Manager and gain approval on adjustments outside of accepted tolerances
Minimum Qualification (education, experience and/or training, required certifications):
Skills:
? PC Skills – Microsoft; SAP, 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 5 years Quality experience in a GMP/GSP environment.
Qualifications:
? Tertiary qualifications in Science or related field
? Registered Pharmacist (if required by local laws)
