Role Summary
Quality Control manages and oversees the routine inspection, sampling and testing of all incoming materials for production use. This includes a wide variety of materials which are critical for the successful manufacture of the product and delivering a safe treatment for the patients.
The role of the QC Technician, Materials Inspection involves performing the inspection on all incoming materials as per approved procedures and specifications, and liaising with various departments to organise priorities and report on status. Other duties include organising the testing of such materials, liaising with internal and external parties to resolve issues around the inspection and testing, and assisting other departments and stakeholders in the drafting of specifications.
Key Responsibilities
* Inspection of incoming materials by confirming specifications and conducting visual inspection in accordance to procedures and internal specifications.
* Maintaining detailed records of sampling and inspection activities.
* Preparation of samples for chemical and microbiological (where required) analysis and delivering them to the QC lab.
* Assigning and verifying expiry dates for the raw materials through vendor CoA and/or in-house specification documents.
* Coordination and collaboration with warehouse team (e.g., pick of materials/samples, internal and external materials/samples transfers and shipments).
* Management of non-conformances.
* Compliance of warehouse areas in terms of isolation of quarantine, released and rejected raw materials
* Supporting QMS activities as required (OOS, CAPA, and change controls), to facilitate testing, qualification, system improvements and compliance.
* Working with other departments to plan and prioritise the inspection and release of materials.
* Ensuring compliance with local SOPs, policies and protocols Forms.
* Supporting documentation management.
* Drafting of SOPs and reports.
* Operating in compliance of cGMP.
* Any other duties as required following consultation with the post holder.
* Work in adherence to local Health and Safety policies and SOPs.
Demonstrated skills and competencies
E – Essential
P – Preferred
Experience
* Minimum 1 year experience on inspection of raw materials in a GMP environment (P)
Qualifications
* 5 GCSEs including English, Maths and Science (E)
Skills/Specialist knowledge
* Soft skills (effective written and spoken communication, organisation, teamwork) (E)
* Ability to precisely follow instructions and procedures (E)
* Attention to detail (E)
* Ability to use Office 365 tools (design of basic spreadsheets, tables, documents) (P)
* General awareness of different regulatory frameworks (e.g., EudraLex, ICH, FDA) (P)
* Basic understanding of GMP principles as applied to QC (E)
* Understanding the operation of QC laboratory (P)
* Working knowledge of Quality Management System records (e.g., deviation, CAPA, laboratory investigation, change control) (P)
* Experience in LIMS (P)