Quality Associate Complaints- External Network - REMOTE
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SummaryThanks for checking out our vacancy, we're delighted you want to learn more about Dechra!Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do businessThe Opportunity Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra.Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do businessThe Opportunity Reporting into the Associate Quality Director- External Network (CA/US/MX), and working closely with the Quality Specialist Complaints - External Network, the Quality Associate Complaints - External Network will be responsible for:Working with internal Dechra stakeholders and External Manufacturing Partners in order to ensure that all Product Defect Complaints received are promptly and properly handled, assessed, investigated, reviewed, and documented. Support the compilation and reporting of complaint metrics to internal stakeholders and External Manufacturing partners in order to ensure any potential signals are detected evaluated and acted on. ***This is a remote role and can be located anywhere in the United States***Main ResponsibilitiesSo, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including:To work with the Quality Specialist - Complaints in the External Network and internal stakeholders on the management and roll out of the global harmonised process for the management of product defect complaints.To initiate, handle and close records for complaints regarding Dechra Product according to established Standard Operating Procedures.To facilitate the return of complaint samples from the market to the appropriate investigating site in a timely manner.To determine if the complaint involves the possible failure of a drug product to meet any of its specifications. To ensure complaints that are potentially received due to a defective product are directed to the appropriate external manufacturing site.To escalate to internal stakeholders quality defects in distributed drug products that may present a potential safety risk.To ensure that written records of each complaint received from external manufacturing partners are clear, comprehensive and where justified identify appropriate corrective and preventive actions.To communicate in a timely manner with internal stakeholders, and external partners in order to ensure that defined timelines for investigation and reporting are adhered to.To ensure that where EU manufacturing facilities are included in the supply chain for the product the Qualified Person involved in the certification for release of the concerned batch or batches, are formally made aware of any investigations, any risk-reducing actions and any recall operations, in a timely manner.To ensure that where a complaint defect could potentially be due to falsification, the complaint investigation investigates the potential that the product has been falsified.To confirm the Dechra quality expectations from Dechra's External Network manufacturing Partners demonstrating maturity, integrity experience and knowledge of subject.To provide or support the assessment of Dechra complaint data to enable the accuracy of provided Product Quality Reviews (PQR's) to be assessed.To ensure product defects which potentially require product recall are escalated in a timely manner for evaluation by internal stakeholders.To ensure effective communication to drive the quality agenda, to liaise and co-operate with all other Departments to ensure good communication and timely identification and resolution of issues.Ideal CandidateHere at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We're particularly excited to hear from those who have/are:Qualifications:Bachelors degree (Pharmacy, Chemistry, Biochemistry or equivalentKnowledge and Experience:Proven experience in a quality roleDetail orientedDiplomatic with good listening skillsConfident, and effective communicatorPro-active and solutions driven, with the ability to work to strict deadlines with a high level of accuracyProven ability as an effective communicator with ability to collaborate and form strong partnerships within teams and diverse stakeholders /customers that result in "win-win" outcomes to achieve business goals and objectivesProficient in Microsoft Outlook, Word and ExcelHighly self-motivated with strong inter-personal skillsAbility to work with cross-functional teams on new process projects and process improvementsAbility to prioritize work and handle multiple deadlines