Careers

 

Quality Technician

Job Title: Quality Technician
Location: Hay on Wye
Department: Quality Assurance
Reporting to: QA Technical Manager, Principle Quality Technician
Responsible for (staff): N/A

General Purpose of Role:

  • An opportunity has arisen for a Quality Technician to join the Quality Technical team. The successful candidate will provide assurance of the quality of the packaging process by audits and inspection processes. They will provide support and training to the production group.
  • The successful candidate will have good communication skills along with the ability to identify and solve problems. The ability to produce relevant documentation is also required

Main Responsibilities:

  • Inspection of packing lines before materials are introduced to ensure freedom from materials from a previous operation and the equipment has been cleaned as per the relevant SOP.
  • Carry out in-process checks on Clinical Trials as specified in the CT packaging instruction.
  • Perform documentation audits of cubicles; including challenges, in-process records, line clearances, end of line inspection and overall documentation completion and accuracy to increase RFT, working actively with the production team to resolve any issues which have been identified.
  • Perform housekeeping inspections of cubicles including for example spot checks of log books, SOP’s and training records; actively working with the relevant departments to resolve any issues which have been identified.
  • Advising the Principal Quality Technician of any abnormality observed with a product, component or finished product found during inspection. Escalation to the Quality Technical Manager if required.
  • Ensure that all scales, leak test equipment used within the production environment is calibrated and maintained.
  • Checking of clinical trial and commercial labels for accuracy.
  • Supporting training and competency assessment, of production and quality personnel, including challenges, in-process checks and booking in/verification of materials; maintaining the training matrix and quality assessment records for each individual.
  • Start initial investigation and generate Exceptions relating to trending issues highlighted within quality audits and IPC’s.
  • Carry out complaint investigations.

Specific Qualifications:

  • A technical or vocational qualification equivalent to an NVQ level 2

Previous Work Experience:

  • Relevant experience within GMP or similar environment.
  • Experience of working to quality standards.

Specific Knowledge / Skills Competence:

  • Relevant knowledge of quality related procedures & documentation.
  • Understanding of GMP and the Quality Assurance role within GMP.
  • Ability to produce relevant documentation to the required standards.
  • Ability to train and develop others
  • Good IT skills (Microsoft Office)

Behavioural Competencies:

  • Good communication skills
  • Ability to identify and solve problems
  • Decision making skills
  • Flexible within working patterns
  • Ability to work unsupervised.
  • Ability to influence others.
Posted on Categories EU, EU Hay-on-Wye, Vacancies

Back to careers

Leave a Reply

Your email address will not be published. Required fields are marked *

4 × two =

Explore the PCI Process Phase by Phase

PRE-CLINICAL
PHASE I
PHASE II
PHASE III
COMMERCIAL

Swipe to explore the PCI Process

PRE CLINICAL

pre-clinical-icon
  • Formulation Development
  • Analytical development/characterisation

PHASE 1

PCI Phase 1
  • Formulation Development
  • Analytical Development
  • Drug in capsule/vial technology (Xcelodose)®
  • Phase I product manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase I packaging and labelling
  • Storage and distribution

PHASE 2

PCI Phase 2
  • Formulation Optimization
  • Dosage Form Process Validation
  • Analytical Testing and Stability Services
  • Phase II Product Manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase II packaging and labelling
  • Storage and distribution

PHASE 3

PCI Phase 3
  • Comparator Sourcing
  • Scale Up Studies
  • Phase III Product Manufacture
  • Tablets/Capsules
  • Blinding via over-encapsulation
  • Phase III packaging and labelling
  • Analytical testing and stability services
  • Storage and distribution

COMMERCIAL

PCI Commercial Phase
  • Scale up for commercial supply
  • Commercial product manufacture
  • Commercial packaging and labelling
  • Validation services
  • Analytical testing and stability services
  • Product release to market
  • Storage and distribution

PCI Points...

You told us what aspects you value as "very important" when choosing a vendor...

Why choose us...

Our global reach and localized support ensures PCI as a strategic partner remains focussed on delivering speed-to-market and the commercial success of our customers

PCI is a global company that focusses on delivering speed-to-market and the commercial success of our customers

Why choose us...