QA Technical and Regulatory Specialist

4 weeks ago

Skipton, United Kingdom Dechra Full time
Summary

Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra.

Dechra are 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.

So what's the role?
The role of the QA Technical & Regulatory Specialist is to effectively lead and support the quality assurance improvement activities with a focus on technical support to the Quality Team and the wider site by analysing and promoting changes, creating solutions based upon data, technical understanding and regulatory intelligence.

Supporting the delivery of new initiatives and new/exiting products to the site to enhance capabilities and compliance. Building robust systems in line with the Dechra Quality standards and with the Quality Vision and culture to support and enhance the department and site into the future.

Package
  • Average 36-hour working week (with a day off every other Friday)
  • Shift is 8am-4.30pm Mon-Fri
  • Plenty of training and development opportunities
  • 22.5 days annual leave + Bank holidays
  • Option to buy a week's holiday each year
  • 8% Employer Pension Contribution
  • Free access to the Headspace App
  • Employee Assistance Programme
  • Free on-site parking
Main Responsibilities
  • Lead GMP compliance activities to the required quality standards
  • Provide high level of support and governance of functional areas to ensure quality assurance is built into the processes, in particular QC and Manufacturing activities.
  • Develop new quality approaches and improvement initiatives to support future scale and evolving legislative compliance (high focus on quality mind-set creation and Quality Risk Management).
  • Interrogation of current Licenses for compliance
  • Act as a QA Trainer, Mentor and Assessor
  • Act as QA SME for significant non-conformance investigations by supporting progress and product impact assessment using Practical Problem Solving and RCA tools to good effect
  • Ensure Operational Excellence is utilised in support of Quality initiatives. This should include adopting a philosophy of continuous improvement and a "Right First Time" attitude to all operations. Proactive focus will be taken to address historical quality issues and non-value adding activities
  • Investigate incidents of process validation, manufacturing or processing deviations or abnormal occurrences making recommendations regarding product compliance, consequent release and actions to prevent re-occurrence
  • Review quality issues at the start of each shift with a view of prioritising work load and ensuring key quality issues and business priorities are addressed and escalated appropriately and resolved in a timely manner
  • Effectively lead quality investigations, communicate with customers in relation to major changes/investigations and chair incident meetings
  • Apply problem solving capabilities to determine root causes of issues and identify effective CAPA to increase right first time and improve efficient and reduce operating costs
  • Conduct QA reviews and manage the approval process of master manufacturing/ packing documentation
  • Support respective area manager in root cause investigation and help in closing deviations and CAPAs in timely manner
Ideal Candidate

Here at Dechra we pride ourselves on being an inclusive employer and we encourage applications from a variety of different work backgrounds. We're keen to learn a little more about you and your career. The following skills/experiences will stand you in good stead:

  • Excellent organisational skills
  • Ability to work cross functional
  • Excellent Time Management skills
  • Excellent training skills
  • Leadership Skills
  • Influencing Skills
  • Attention to detail
  • Considerable level of scientific experience
  • Considerable level of experience in a GMP environment preferably in the pharmaceutical industry in an operational role within QA, QC, Manufacturing, Technical Support
  • Demonstrated knowledge of Quality Systems
  • To be knowledgeable regarding the validation and operation of manufacturing processes and analytical methods and associated equipment, facilities, automation and information management systems
  • To be familiar with product development, manufacturing, quality assurance and quality control systems
  • To be able to write standard GxP documentation independently
  • Must be able to deliver a range of QA training packages
  • Expert knowledge of GMP standards
  • Good knowledge of electronic quality systems
  • Knowledge of EU and FDA manufacturing license (CMC) and import/export license
  • Educated to degree level or equivalent in Chemistry, Pharmaceutical Science, Life Science or other similar disciplines.

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