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Quality Assurance Associate AQL

Please Note: The application deadline for this job has now passed.

Job Introduction

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

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 

  • To work in the Quality Assurance Department and perform AQL inspections on the Operations floor.
  • The QA Associate works closely with QA operational and compliance teams in a support function to ensure compliance to relevant SOPs and cGMP standards.

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:

The QA Batch Record Release Associate functions includes but are not limited to:

  • Supports Continuous Process Verification checks.
  • Preparation and review of Standard Operating Procedures.
  • Track and report on the daily basis any issues found on the Production Batch Records.
  • Archiving of master paper documentation.
  • Retrieval and control of quality/cGMP documentation.
  • Assist with creating and issuance of batch records and related batch documentation for the weekly manufacturing schedule and issue-controlled copies of manufacturing forms as needed.
  • Create and revise documentation related to non-conforming product and ensure that all affected material is properly labelled for disposition.
  • Perform quality inspections of production activities that include the following:
  • Inspect and approve production rooms and equipment. 
  • Inspect rooms and equipment for cleanliness.
  • Verify logbooks and cleaning and sanitization activities.
  • Inspect and approve products and associated materials and components and ensure they are correct for the batch.
  • Perform in-process inspection checks in Solid Dose Mfg. and Pkg.
  • Pull and issue label for packaging department according to weekly schedule, as well as returning unused labels to label cage area. Labels will be pulled when production schedule is issued by logistics, or as necessary for other projects.
  • Apply In-Process, Approval, Quarantine, or Reject stickers on components, labels, or raw materials packaging.
  • Inspect and verify equipment calibration is current.
  • Perform daily filling line checks including initial line clearance check, packaging and label verification and final postproduction line clearance.
  • Perform AQL inspections of packaged finished product as required. Includes inspection, documentation of results and coordination with packaging department for any reinspection required.
  • Support with Area Key Performance Indicators.
  • Display cGMP attitude at all times.
  • Prioritise own workload and ensure key quality issues and business priorities are addressed, escalated appropriately and resolved in a timely manner.
  • Support Quality Events on site (deviations / incidents / CAPAs).
  • Any other duties which may properly be assigned to this post.
  •  

    Planning and Organizing

    Attention to detail

    Team working

    Task focused

    Adherence to standards

    Competencies

     

     

     

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:

 

Essential

Desirable

Behaviour and Values

(D) Committed to delivering excellence

(E) Enthusiastic and results driven

(C) Able to take calculated risks

(H) Honesty and integrity

(R) Team player

(A) Willing and able to go the extra mile

 

Skills

 

Organizational skills.

Good numeracy and literacy skills.

Excellent communications skills.

Word processing skills.

Excellent attention to detail.

Ability to work on own initiative as well as part of a team.

Ability to multi-task, set priorities and meet strict deadlines.

 

Qualifications

 

Educated to Grade C or above GCSE (or equivalent) in Mathematics and English

 

Knowledge and Experience

Previous experience of working in a cGMP manufacturing environment or related experience.

Previous experience working with FDA is strongly encouraged.

Knowledge of document systems.

Experience of assimilating contents of written documents quickly and accurately.

 

 

 

General appreciation of factory operating systems is desirable

 

 

 

 

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 employee stock purchase plan 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

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