Full job descriptionQuality Officer (GDP) - East Midlands
Location: Hybrid East and West Midlands
Salary: - £37-42,000 + Benefits
Are you passionate about ensuring quality and compliance? Do you thrive in a dynamic environment where your organisational skills can shine? If so, we have an exciting opportunity for you! Our client is seeking a dedicated Quality Officer to join their team and play a vital role in maintaining the highest standards of quality assurance.
Your Tasks:
As a Quality Officer, you will be the backbone of our quality assurance processes. Your responsibilities will include:
*Providing QA support to internal departments, ensuring compliance with Good Distribution Practise (GDP) and organisational procedures.
*Offering quality assurance advice to operational teams to enhance process compliance.
*Initiating and maintaining change control, deviation, and Corrective and Preventative Action (CAPA) records, ensuring effectiveness in proposed activities.
*Providing administrative support for scheduling suppliers, internal audits, and annual reviews within the QA framework.
*Collating data for reports, investigations, key performance indicators (KPIs), and other quality metrics.
*Participating in the self-inspection audit programme, assisting the QA management team as needed.
*Preparing for client audits and regulatory inspections by organising documents and ensuring internal team readiness.
*Supporting the Supplier Management process through verifications, audit actions, and surveys.
*Aiding in the upkeep of the Quality Management System in alignment with GDP, ISO 9001, and ISO 13485 standards.
*Building strong relationships with internal and external stakeholders related to QMS activities and non-compliance actions.
*Ensuring compliance with QMS activities during client onboarding, including validation, SAP testing, and process walkthroughs.
*Reporting KPIs to the Global QA team and supporting ongoing compliance with the Global Quality system.
*Overseeing product quality, process safety, and complaint investigations.
*Completing QA reviews on inbound packs, return documentation, and temperature data management, adhering to ALCOA principles.
Your Profile:
We are looking for someone who is organised, methodical, and adept at prioritising a busy workload. You should be comfortable liaising with stakeholders and customers at all levels.
Key Qualifications:
*Experience in quality administration, including managing busy mailboxes, document control, scheduling, and conducting audits.
*Proficiency in supporting QMS activities: investigations, complaint management, gathering change control evidence, and compiling KPIs.
*Knowledge of Good Distribution Practise (GDP), ISO 9001, and ISO 13485, along with familiarity with systems such as SAP, electronic QMS, and temperature monitoring portals.
*Competency in Office applications (Word, Excel, Visio, Projects, etc.).
*Previous experience in quality assurance within healthcare, medical devices, or pharmaceuticals is a plus, but not essential!