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QA Officer

Central Employment Agency (North East) Limited
Job LocationCramlington
EducationNot Mentioned
Salary£25,000 - £30,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeTemporary, full-time

Job Description

We are seeking 3 experienced quality assurance officers to support merger and acquisition activities relating to quality systems, at a pharmaceutical company in the North East of England for approximately 12 months.You will be working with the QA team at our site in Northumberland in this multi-faceted position to actively support Quality Systems and GMP practices throughout the site.Do you have a quality mindset and the ability to work in a fast-paced environment managing multiple deadlines and requirements, and would you like to work for a leading organisation in the pharmaceutical industry Then we are looking for you!About the RoleCompliant, reliable supply is the foundation of our business and the aim of the role is to support the various quality system activities impacted as a result of the merger and acquisition, e.g. change control, Quality Risk Management, auditing, document management, quality management, laboratory systems, GMP training, artwork, and supplier management to name a few.Having a quality mindset and the ability to work in a fast-paced environment managing multiple deadlines and requirements are paramount to succeed in this role.You Will:

  • Work closely with the QA team and site sub system owners to ensure successful project execution, and ensure the full change impacts per system are well understood and mitigated by relevant stakeholder by:
  • Identifying and implementing internal controls required to stand-up the quality processes/systems in support of merger and acquisition activity.
  • Facilitating on-time execution of multiple activities across the different work streams.
  • Identifying gaps and working with stakeholders to resolve in compliance with internal standards and EU Good Manufacturing Practice (GMP).
  • Involvement with the various document systems, e.g. Trackwise, SAP, QualityDocs etc.
  • Supporting change management activities relating to the spinoff and site compliance activities.
  • Providing support for routine QA activities during the merger and acquisition activities.
    • You Are
  • Detail oriented, ensuring the full change impacts per system are well understood and mitigated by relevant sub system owners, and you follow up with the various stakeholders to ensure all items are progressed and closed within given deadlines.
  • Fast Acting, someone who is comfortable working largely unsupervised whilst supporting the execution of the various Quality Workstream deliverables.
  • Collaborative, capable of working cross functionally, a highly motivated self-starter demonstrating ability to use initiative with respect to scheduled work activities.
    • You Bring:
  • A good understanding in the principles of Quality Management Systems e.g. ISO 9001, Pharmaceutical Pharmaceutical Quality System (ICH Q10), with experience in working in a GxP (GLP/GDP/GMP) environment (in the healthcare or pharmaceutical industry is an advantage).
  • Familiarity with databases and MS Office applications; Trackwise and SAP highly desirable.
  • Strong communication skills with an ability to positively communicate with all levels of the organisation.
  • Overall work experience of 5+ years with 1 or more years of relevant quality assurance or quality system experience preferably within a GMP/regulated environment.
    • If you relish the opportunity to help shape our quality management system and be a part of a strong and diverse team of professionals in an open and flexible environment and would like to be considered for this exciting position, then please submit your CV. Required skills
  • Change Control
  • GMP
  • Pharmaceutical Industry
  • Quality System

    • Keyskills :
    Change Control GMP Pharmaceutical Industry Quality System

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