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QA officer

QA officer

  • Location

    Oxfordshire, United Kingdom

  • Sector:

    Quality & Validation

  • Job type:

    Permanent

  • Salary:

    £30,000 - £35,000 + Benefits

  • Contact:

    Joe Lane

  • Job ref:

    35400

  • Published:

    over 1 year ago

  • Expiry date:

    2019-02-25

  • Consultant:

    #

 

Quality Assurance Scientist

 

Location:

 

Oxfordshire

 

 

Summary of Job Description:

 

The QA Scientist is responsible for the maintenance of the Quality Assurance activities and Quality Management System (QMS)..

Assisting Senior Management and the Senior QA Scientist to evaluate and assure appropriate

Quality   Systems   are   in   place   at   approved   vendors   and   suppliers   providing   Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) services.

Ensuring all relevant quality and regulatory requirements are met for quality control testing and  contract  manufacturing.  Ensures  site  compliance  with  Quality  Systems  Regulations

issued  by  MHRA,  FDA  and  other  applicable  regulatory bodies  where  our  products  are being developed.

 

 

Key Responsibilities:

 

      Assist  the  Senior  QA  Scientist  to  develop  and maintain the Quality Management System in accordance with applicable standards established by MHRA, FDA and other applicable regulatory bodies.

      Interface with internal teams in Product Development, QC, Clinical, Research and, as appropriate, with external vendors such as Contract Manufacturing Organizations, and other  service  providers  to  ensure  compliance  with  the  requirements  and  quality standards.

     Participates in coordinating daily activities within the assigned functional area.

     Provide support to Product Development for regulatory activities, to facilitate CTA and

IND approvals of the Company’s pipeline of exosome therapeutics.

 

Other Responsibilities:

 

      Ensure  QA  standards  are  maintained  in  control  of  documentation,  staff  training, facilities, equipment, and archiving.

     Assist in the development, management and review of the site validation plans.

      Draft, review and provide oversight to content of documents which may include but are not limited batch records, Assay sheets, logbooks, material specifications, and

SOPs.

      QA review and approve all technical documentation from research, development and clinical function. This will include, but is not limited to, SOPs, reports & protocols, laboratory notebooks, in-house batch records, facility & equipment records.

      The preparation of reports, certificates of analysis and regulatory documents in support of submissions to regulatory authorities.

 

 

      Assist  in  the  management  programme  of  internal  and external audits.

     Participate in internal audits as required.

     Assist in QA and OOS investigations.

      Provide  QA  support  for  the  development  of  new  processes  or  testing  methods developed.

     Generate metrics for the monthly Quality Management System meeting.

     Assist/Lead in staff training in QA procedures.

     Monitor GCLP testing of clinical samples.

      Ensure regulatory compliance  in  all countries that operate or  conduct  clinical trials.

 

 

 

Educational requirements:

 

     Degree (BSc) in an appropriate science subject

 

Experience and skill requirements:

 

      1+ years relevant work experience within the pharmaceutical/biotech industry in a QA function. The holder is likely to have other relevant experience within the industry, such as QC, GLP, GCP or GMP production.

     Familiarity with FDA/MHRA regulations, ICH guidelines and current industry practices.

     Ability to define problems and prioritise issues.

      Ability to plan and organise workload including evaluation and prioritisation of current tasks and forward planning for future events.

     Demonstrate ability to make decisions, take responsibility and exercise judgement.

      Use initiative to resolve problems, anticipating and pre-empting situations and handling pressure.

     Show enthusiasm, energy and commitment to role.

     Strong team player to work towards team goals and effectiveness.

     Demonstrated ability to work in a cross-functional team environment.

     Good verbal and written communication skills.

     Have strong computer software skills.