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R&D Quality Assurance Officer

  • Salary: Negotiable
  • Job type: Permanent
  • Location:
  • Sector: Quality & Compliance
  • Date posted: 27/08/2018
  • Job reference: BBBH15509

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R&D Quality Assurance Officer

Job description

To support our clients new R&D Manufacturing facility we are recruiting for the role of R&D Quality Assurance Officer to support the R&D Quality Assurance Team . The new R&D Manufacturing facility will include sterile and non-sterile manufacturing. As a result Quality Assurance support for new equipment qualification, vendor qualification and new product development from conception through to commercialization will be required.


  • To support the Head of Quality and the R&D Quality Assurance Team Lead with the quality assurance function.
  • Support R&D with QA support including but not limited to the following:
    1. batch documentation review
    2. assessment of manufacturing events from a QA perspective.
  • Electronic Documentation Management System - QUMAS
    1. Check own work and that of others for accuracy before / prior to 'QA Authorisation' of documentation.
    2. QA reviewer of Process Compliance Change Controls
    3. Progress Process Compliance actions and attach evidence as required.
  • Perform internal audits as scheduled by our clients.
  • Review and approval of Regulatory deficiency responses.
  • To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • Report any safety or compliance issues as per our clients procedures.
  • Attend Product review meetings and provide support on the development of new Products
  • Liaise with regulatory affairs/ formulations / laboratory personnel to ensure regulatory and quality requirements are met.
  • Assist with review of Submission Documentation in support of license applications and customer requirements.
  • Noncompliance reporting and corrective action / continuous improvement implementation.
  • Operation of our clients SAP (ERP System) Quality function as per procedures.
  • Support the on-going OOS/IR/CACI closeout programme.
    1. Complete any assigned actions in the agreed time frame.
    2. Investigate any incident assigned in a timely fashion.
    3. Review deviation investigations and actions as required.
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • To support on-going projects with respect to the following:
    1. Vendor review and approval
    2. URS review and approval
    3. Equipment qualification review
  • Health & Safety
    1. Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
    2. Report any hazard

Minimum Qualifications & Experience:

  • BSc (Require Quality Management as a part of degree)
  • Minimum of 2 - 4 years QA experience in a GMP compliant role
  • Experience with desktop and internet-based software applications (e.g. electronic document management system, MRP system) an advantage but not essential.
  • Excellent communication and presentation skills
  • Focus on quality and detail
  • Careful planning to achieve accurate and timely results
  • Ability to define and manage own tasks and schedules
  • Experience performing and assessing risk/impact assessment an advantage
  • Sterile manufacturing experiences would be of benefit