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, Dedication, Enjoyment, Courage, Honesty, Relationships, and Ambition are at the heart of our everyday operations and the way we do business.
The Opportunity
* Responsible for the disposition of finished products received from Dechra’s External Network of Contract Manufacturing Organisation (CMO) and imported into the United States (US) from Dechra’s Internal Network of manufacturing and distribution facilities.
* To support the US market on quality issues related to storage and distribution in accordance with Dechra Standards and legal requirements to ensure compliance with Good Distribution Practice within the distribution chain in the territory.
* To support the management of unlicensed product and in licensed VMPs.
* Support Supply Chain on quality issues related to 3PL warehouses.
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 ensure that the GDP systems, processes, and agreements that support batch disposition to the US market are managed and maintained.
* To ensure that clear, complete, and accurate records of batch disposition are compiled and retained.
* To ensure that training programmes are followed and developed for any new or revised GDP process.
* To coordinate and promptly provide any data associated with batch disposition required to support recall activities for products dispositioned.
* To support the development of Standard Operating Procedures (SOPs) and Working Instructions (WI) associated with GDP activities.
* To provide data to External Network Quality Specialists / Managers on returned, rejected, recalled, or falsified products to support their disposition decision.
* To ensure any communicated additional requirements imposed on certain products by national legislation are adhered to.
* To ensure that timely communication with internal and external stakeholders in order to ensure that documentation received from CMO’s, and internal Network sites is properly evaluated and filed with batch disposition documentation.
* To ensure that incidents and deviations associated with records received for disposition are reviewed and approved prior to batch disposition.
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:
* Proven QA / quality associate capabilities in a quality role.
* Detail oriented.
* Diplomatic with good listening skills.
* Mature, 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 the 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.
* Fully IT literate: Microsoft Outlook, Word, 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 prioritise work and handle multiple deadlines.
* Demonstrated pharmaceutical quality experience, including working within quality systems such as batch disposition, document management, audit programmes, change control, complaint handling, and investigations.
* A knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and working knowledge of US FDA applicable CFR’s.
* Experience of back room support for regulatory inspections, client audits, and self-inspections.
* 2 plus years of relevant Quality Assurance experience.
* Bachelor degree (Pharmacy, Chemistry, Biochemistry or equivalent).
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