Quality Assurance Associate
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.
To assist Qualified Persons in Release Production Batch Folder activities within the Quality Assurance Department and to 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.
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 Release functions includes but are not limited to:
- Provide support to the Quality department including the following:
- Scanning/sending batch records to internal and external customers
- Control, distribute & archiving of incoming quality documentation
- Production & issuance of COA’s/CofC’s
- Training system filing activities
- Review of batch documentation to ensure compliance to method and relevant procedures.
(Support in checking to ensure that Deviations, Change Controls and Validations are in suitable status, documentation completeness and all critical control points are complied with prior of releasing the Production Batch Folder).
- Supports Continuous Process Verification checks
- Liaises with the Supply/Planning Team to ensure product release is in line with Supply/Planning requirements.
- Preparation and review of Standard Operating Procedures
- Issuance & control of batch records
- 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 including logging distribution details
- 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 both Liquid and Solid Dose Mfg. and Pkg.
- 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
- 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
- Test incoming labeling receipts according to written specifications and label standards and assist with testing and write up of incoming packaging components
- Test packaging components according to written specifications using calibrated measurement equipment as needed and document testing in notebook according to procedure;
- Apply In-Process, Approval, Quarantine, or Reject stickers on components, labels, or raw materials packaging
- Verify completed finished product count sheets at end of each run
- 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
- Create, revise documentation related to non-conforming product and ensure that all affected material is properly labeled for disposition.
- 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
- Update and create Standard Operating Procedures
- Support Quality Events on site (deviations / incidents / CAPAs)
- Assist with internal audits
- Any other duties which may properly be assigned to this post
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:
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
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
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
Previous experience working in an Office environment
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