Quality Assurance Specialist

3 weeks ago

Skipton, North Yorkshire, United Kingdom Dechra Full time
About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team at Dechra. As a key member of our Quality Team, you will be responsible for leading and supporting quality assurance improvement activities, with a focus on technical support to the Quality Team and the wider site.

Key responsibilities will include analysing and promoting changes, creating solutions based upon data, technical understanding and regulatory intelligence. You will also support the delivery of new initiatives and new/existing products to the site to enhance capabilities and compliance.

As a Quality Assurance Specialist, you will be responsible for 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.

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).
  • Interrogate 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
Requirements
  • 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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