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Senior Quality Assurance Officer

Employer
Simbec-Orion
Location
Homeworking, UK
Salary
Competitive
Start date
6 Sep 2021
Closing date
6 Oct 2021

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we'll adapt our delivery style, communications and operations to suit the demands of your project, helping you achieve your clinical and commercial objectives. Because our goal is the same as yours; to improve patients' lives.

Summary of the Position:

We are looking for a Senior Quality Assurance Officer to join our Quality Assurance department. You will be based remotely in the UK.

You will carry out QA responsibilities as assigned whilst supporting Simbec-Orion in enhancing a 'Quality First' culture delivering Quality by Design services that deliver Patient Safety, Data Integrity and Regulatory Compliance across all of our operational departments.

You will apply a risk-based, data-driven approach across the group to Build, Consolidate, and improve an organisation that excels at identifying risk, taking appropriate mitigating action, and effectively managing quality issues.

Key Accountabilities:
  • Oversee the implementation and appropriate update/improvement of the Quality Management System, including ongoing development and maintenance of QA systems and procedures.
  • Produce and manage the Audit Schedule in collaboration with QA Management.
  • Prepare and support for Regulatory Inspections and Sponsor Audits in collaboration with QA Management.
  • Generate and report on key quality indicators and generate Quality assurance and Management reports as required.
  • Escalate and follow up on quality issues according to required timelines.Conduct audits and document reviews as assigned in line with the Audit Schedule and in accordance with the appropriate SOPs.
  • Evaluate non-compliance actions (CAPA) and root cause analysis.
  • Provide training for employees in Quality Assurance procedures and GCP.
  • Maintain awareness and knowledge of current developments relevant GxPs, regulatory requirements/ expectations and industry trends.
  • Support operational departments through the provision of consultancy support and guidance on Quality issues.
  • Take a leadership role within the QA team on assigned projects/ responsibilities.
  • Deliver on any other QA projects as assigned by QA Management.

Minimum Requirements:

Essential:
  • Previous experience working in a QA/Quality Management role within a GCP regulatory environment
  • Ability to complete assignments and deliver on responsibilities with minimal supervision
  • Experience in auditing to GCP quality standards
  • Excellent decision-making and problem-solving skills and experience in addressing significant non-compliance, including Root Cause Analysis, Corrective and Preventive Action
  • High level of attention to detail and high-quality standards, maintaining data integrity, works effectively and constructively in a regulatory environment
  • Previous experience of working cross-functionally with other departments and project teams to plan and overcome challenges
  • Excellent time management skills and ability to effectively manage changes to priorities and deadlines
  • Experience in driving change, positive champion of change, flexibility and adaptability to meet the changing needs of the business.
  • Ability to keep functioning effectively and respond constructively in a fast-paced environment or in response to challenges arising

Desirable:
  • Life Sciences Degree or equivalent
  • MSc in Quality Management
  • Experience in auditing in further GxPs (e.g. GMP/GLP/PVG/CSV)
  • Experience hosting and responding to sponsor audits and/or regulatory inspections
  • Strong leadership of project teams and influencing skills
  • Experience in training employees (within QA) or departments on GCP and SOPs
  • Experience in upskilling employees to ensure GxP quality standards are maintained

Simbec-Orion Job Profile - Senior Quality Assurance Officer.pdf

Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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