Quality Associate Complaints– External Network - REMOTE
Job Introduction
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 business
The 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 business
The 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***
Role Responsibility
So, 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.
The Ideal Candidate
Here 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:
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Qualifications:
- Bachelors degree (Pharmacy, Chemistry, Biochemistry or equivalent
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Knowledge and Experience:
- Proven experience in a quality role
- Detail oriented
- Diplomatic with good listening skills
- Confident, and effective communicator
- Pro-active and solutions driven, with the ability to work to strict deadlines with a high level of accuracy
- Proven 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 objectives
- Proficient in Microsoft Outlook, Word and Excel
- Highly self-motivated with strong inter-personal skills
- Ability to work with cross-functional teams on new process projects and process improvements
- Ability to prioritize work and handle multiple deadlines
About the Company
As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and an other incentives for long-term financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.
Dechra Pharmaceuticals PLC