Senior QA Specialist

Highly Competitive
  1. Permanent
  2. Senior/Director & VP, Good Clinical Practice (GCP)
  3. United Kingdom
Hertfordshire
Posting date: 21 Jun 2019
QA.JG.23959_1561125394

A leading clinical-stage biopharmaceutical company that focuses on cancer therapy is recruiting a Senior QA Specialist. The organisation specialises in developing medicines that seek to block tumour immune evasion and offers patients benefits that are far more advanced than current immuno-oncology treatments. This is an exciting opportunity to join this organisation in their UK based office.

The Senior Quality Assurance Officer will support the pharmaceutical quality system embedded within the manufacturing facility used for the manufacture of biological, sterile investigational medicinal products for use in early phase clinical trials. They will promote and support the fundamental principles of Quality and GMP across all departments within the company to ensure the safety and suitability of products manufactured at the BDU.

Job Responsibilities:

  • Providing support to the QA manager in maintaining and developing the QMS.
  • Acting as QA reviewer of deviations and change controls.
  • Following up on corrective and preventative actions in a timely manner.
  • Supporting other departments with regular QA meetings.
  • Performing QA reviews of quality-controlled documentation, including SOPs, BMRs, and reports.
  • Writing QA procedures.
  • Batch records review prior to QP certification.
  • Managing the packing and labelling process for final drug products.
  • Coordinating the shipping of final products to the clinical sites.
  • Performing QA reviews of validation documentation, including mapping of critical storage areas and environmental monitoring.
  • Performing internal and external audits.
  • Working with Production, QA, and development to ensure that materials used are of the correct quality.
  • Prioritising workload with the ability to deputise for QA manager when required.
  • Training staff in QA related procedures.
  • Undertaking internal and external inspections as a representative of the QA function.
  • Demonstrating a good understanding of GMP and its application to IMP manufacturers, particularly sterile biological products.
  • Applying quality and scientific knowledge to identify risks, communicating effectively with a range of people across GMP understanding.
  • Writing effective and clear instructions and reports.
  • Reviewing documents and providing constructive feedback to others.
  • Providing effective training around the principles of GMP and QMS.
  • Providing QA guidance to all staff and influencing other departments.
  • Striving to maintain a high level of competency with current and emerging digital platforms (SAP, EBR, AR/VR, etc).

Skills and Requirements:

  • A demonstrably good understanding of GMP and its application to IMP manufacturing, particularly sterile biological products.
  • Experience of working within a fast paced GMP QA system and be familiar with deviations, change controls, and O
  • Significant experience of QA systems in a GMP environment with knowledge and practical experience of deviations, change control, Out of Specifications, and self-inspections.
  • An ability to assess risks against GMP and internal policies/procedures.
  • Experience with reviewing master BMRs and completed BMRs to ensure that they meet GMP and internal quality requirements.
  • Experience in the application of a pharmaceutical quality system and the principles of ICH Q8, Q9, and Q10.
  • A robust awareness of the legislation surrounding the manufacturing of IMPs within the EU and UK, along with the associated risks.
  • Experience in working with sterile products manufactured aseptically, preferably biologicals.
  • Experience in writing clear instructions covering QA procedures.
  • Experience in the process of validation and qualification and the review of validation documents.
  • Experience of implementing electronic Quality Management Systems.
  • Experience of performing both internal and external audits.
  • Experience of working alongside a QP during batch review, dealing with product complaints and recalls.
  • An awareness of technology transfer challenges into GMP manufacturing.
  • Awareness of Oncology drug development.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Joshua Godden at +442038540101 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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