Quality Assurance Officer

Posted By: George Hixon
Salary: £31,000
Location: Cramlington, Northumberland
Job Type: Temporary
Category: Pharmaceutical

Central Employment are thrilled to offer a 15 – 18 month maternity cover for a QA role in a global, world leading pharmaceutical business based in Cramlington. This role is to fill a maternity gap and requires extensive experience in a similar capacity. This is an excellent opportunity to join a large team working in a pivotal role for the organisation. cGMP understanding is an absolute necessity.

Candidates must have prior pharmaceutical experience 

Key Responsibilities 

  • Provide Quality support for regulatory, global QMS and site QMS requirements. Proactively build Quality into site / department processes, systems and strategies to enable a state of permanent inspection readiness.
  • Ability to lead and/or participate in projects liaising with internal and external customers / stakeholders effectively and efficiently.  Lead and participate in compliance and continuous improvement activities.
  • Develop proactive relationships with key stakeholders, (internally & externally) and perform all activities in accordance with cGMP requirements.  Deputise for the QA Coach.
  • Maintain systems to provide assurance to Site Management of ongoing compliance to regulatory requirements, including:
  • Supporting Quality Unit Activities
  • Lead Compendial review activities
  • Lead Method transfer activities
  • Analytical Standards (inc related analytical change requests) support
  • General Methods support
  • Supplier Acceptance program

The role will also:

  • Be engaged in creating a vision & culture which links to business strategy and goals, promotes health and wellness, and rewards and recognises contributions.
  • Set and achieve clear priorities, provide regular input through developmental 1:1’s, feedback and recognition.
  • Ensure governance and team compliance through company processes, business practices and SOPs to deliver on business goals with the highest level of ethics and integrity.
  • Take accountability for self-development; ensure understanding and application of policies and procedures to enable success for the organisation and to respond to the needs of the business.
  • Provide Support with Audit/inspection requirements to ensure site and department compliance/readiness
  • Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
  • Be required to perform other duties as assigned.

QUALIFICATIONS, SKILLS & EXPERIENCE

  • Previous experience in a Quality role.
  • Experience in project management.
  • Excellent understanding of practices and principles of up-to-date cGMP
  • University degree in Chemistry, Pharmacy or other scientific or statistical discipline or equivalent.
  • Strong Continuous Improvement mindset with experience and skills in the tools

The Person 

  • Ability to be decisive and influence across disciplines and all levels with demonstrated leadership skills to drive change in a compliance culture.
  • Ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities; effective time management.
  • Ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals.
  • Ability to effectively initiate and drive change across multiple site functions
  • Excellent written and spoken communication skills and ability to work in and lead cross-functional teams.
  • A proven ability to form good working relationships with other functional groups.
  • Attention to detail and well-organised approach to working

 

Apply Now!

Personal Details

Curriculum Vitae

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