QA Officer (Healthcare)

This role sits within our healthcare division. This is a hands-on role which requires the individual to be technically knowledgeable about manufacturing compliance, to love problem solving and enjoy working closely with colleagues to drive high standards and achieve goals.  

The position of QA Officer is one of responsibility, working closely with production in respect of quality oversight of manufacturing activities, validation, training, cleanroom compliance and equipment and facilities qualificationThere will be frequent liaison with Operations, delivering quality and compliance activities as well as interfacing with supply chain and other quality colleagues, conducting other activities and initiatives as necessary to maintain the needs of the department. 

The role holder must be able to balance numerous priorities, be incredibly organised and be willing and able to flex and adapt to changing demands of clients and of our business. The role holder must also have impeccable written and communication skills, as well as strong problem solving skills. 

Objectives

  • To implement and manage all day to day operational quality requirements for the healthcare manufacturing division.
  • To support the healthcare manufacturing and warehouse team to deliver high quality products.
  • To maintain and enhance the quality systems required for the healthcare operations.
  • To support new healthcare product and/or project initiatives.

Roles and Responsibilities

  • Presence in production areas to review documentation, perform line clearances and perform QA checks.
  • Working closely with production colleagues to embed and enforce aseptic area quality requirements. 
  • Preparation and review of batch manufacturing and in-process control documentation. 
  • Checking an issuing of labels and production materials to the manufacturing lines. 
  • An accurate review of documentation to prevent deviations and customer complaints. 
  • Investigating deviations and out of specifications as well as planning and executing change control activities. 
  • Managing and executing CAPA actions, which could include writing SOPs and policies, writing SOPs, creating forms and templates, conducting in-house training.  
  • Managing the sending of samples and conduct of testing by third party laboratories.  
  • Creating and reviewing Certificate of Analysis and batch release certificates. 
  • Creating, reviewing and approving qualification documentation.  
  • Planning and managing environmental monitoring within the cleanroom areas. 
  • Planning and managing facilities and equipment qualification, calibration and maintenance. 
  • Checking updates to SOPs, specifications and other quality documentation. 
  • Issuing and disseminating quality documentation.
  • Assisting with internal audits and client audits. 
  • Contributing to the delivery of GMP induction and refresher training and other QMS training as required. 
  • Generating statistics and KPIs to track and monitor performance. 
  • Contributing to document management and archiving activities. 
  • Conducting supplier assessments and approvals, including the issue and reviewing of agreements. 
  • Other duties that may be reasonably required to support the company goals.  

If you want to join a company who is going through an exciting growth phase, send your covering letter and CV to careers@originltd.com.

1