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Quality Assurance Specialist

Just Life Sciences
Job LocationPontypridd
EducationNot Mentioned
Salary36,000 - 44,000 per annum, pro-rata
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract , full-time 3 TO 6 MONTHS

Job Description

Just Life Sciences are seeeking a short term contractor as Quality Assurance Specialist who will be looking to Provide Technical/Quality Assurance within a Pharmaceutical Manufacturer.This is likely to be a 3-6 month contractPurposeTo ensure that all quality aspects of developmental analytical activities on the site are in compliance with current Good Manufacturing Practise standards in accordance with company policies to meet business requirements.ResponsibilitiesTo ensure the timely release of product by the review of the critical process parameters of the analytical documentation (as defined) to assess the quality, safety and efficacy of the products prior to Qualified Person certification.To assist in process and departmental audits against the relevant GMP standards to ensure continued compliance and improvement of systems and processes

  • To assist the Quality Management team in ensuring that all activities on the Tredegar and Oakdale sites are in compliance with current Good Manufacturing Practice standards in accordance with company policies to meet business requirements
  • To work with primarily, the Development department to Ensure analytical raw data for GMP applications is in compliance to GMP throughout the analytical development group
  • Support the standardisation of documentation across the development group to ensure the review process can be consistently applied.
  • Adhere to project timelines
  • Identify self-development needs for future performance.
Main responsibilities:
  • Ensure analytical raw data for GMP applications is in compliance to GMP throughout the analytical development group
  • To perform analytical documentation review of the critical process parameters of testing to ensure compliance with written specifications, SOPs and GMP.
  • To provide KPIs for Right First Time and manage priorities/workload to ensure that reviews are carried out in a timely manner to meet customer expectations.
  • To ensure that, following QA review, analytical documentation is suitable for progression to the QP.
  • To comply with internal and external Health and Safety and environmental standards as required.
  • Assist with internal and external audits.
  • Assist in the review and approval of all documentation relating to development activities to support their continued processes to meet business needs.
  • To liaise with the development groups regarding relevant compliance topics.
  • Review and approval of stability trend reports.
  • Review and approval of deviations raised during method validation.
  • Ensure compliance to cGMP and SOPs throughout the company.
  • To undertake such tasks and to manage specific internal or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holders capabilities and responsibilities.
Interested, then please email your CV to justyn at justlifesciences dot com

Keyskills :
GMPPharmaceuticalQuality AssuranceRegulatory RequirementsBatch Release

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