QA Officer - Drugs & Medicine

New
  • Location
    Nottingham, Nottinghamshire
  • Salary
    £ 20000 - £ 30000 / Year
  • Category
    Medical & Health - Medical Research & Laboratory Sciences
  • Job type
    Contractor
  • Industry
    Science
  • External Reference
    JN-122018-40382

*Must have experience writing SOPs*












Overall Job Purpose:




  • Responsible for managing the day-to-day running, maintenance and continual improvement of Quality Systems at Juniper Pharma Services

  • To support the quality aspects of client projects to ensure they are conducted in accordance with our clients' Services ' quality procedures.


� Supporting the Technical and Formulation Teams to enable that all instruments, processes and procedures meet GMP requirements.




















Main Duties:




  • Manage allocated Quality Systems used within MP, such as Change Control, CAPA, document control, Internal Audit, External Audit, Unplanned Deviations, Facility and Equipment Validation, Quality Agreements and ensure compliance with site SOPs

  • Author and Update SOPs as required to support the required Quality System at MP

  • To participate, as Authorised Auditor, in the internal audit System for our client

  • Provide support for the materials management approval process, including performing risk assessments and audits as required.

  • Support site audits by Clients or Regulators.

  • Support site supplier approval process, including auditing as required.

  • Support provision of site metrics, as required, for review by the Qualified Person and Senior Management.

  • Provide Quality support, as required, to Juniper Pharma Services . Maintain knowledge and awareness of the latest developments and seek to apply within.

  • Work with the Qualified Person to ensure that client projects are delivered to agreed quality standards and meet client specifications within agreed deadlines.

  • Provide Quality Support to the Formulation and Technical team to ensure instruments are appropriate maintained, calibrated, validated/verified and reported (where necessary).

  • Ensure all Quality Systems are compliant with the IT folder structure and any issues reported.

  • Support Quality System aspects of MP Analytics project work, as required, to ensure Technical Team complete projects to required standard.

  • Support Quality System aspects of MP Formulations laboratory work conducted by the Technical Team or subcontractors to allow this to be conducted to a high degree of quality such that it will stand up to external scrutiny.

  • Ensure Qualified Person is informed of quality issues as required by site procedures.


� Ensure that all work is conducted in responsible and safe manner in accordance with Juniper Pharma Services Health and Safety policies and ensure that all Health and Safety considerations are appropriately documented.



Skills and Experience:



� Minimum of three years working in a GMP Environment, within a Quality Assurance function.


� A degree in a science based subject


� An understanding of Quality Systems relating to Pharmaceutical Development and Manufacturing of clinical trial products.


� Knowledge of EU and US GMP regulations, supported by ICH and WHO


� Trained to conduct audits, internal and external to required GMP standards


� Experience of Client/Regulatory audits


















Technical Competencies:




� GMP compliance


� Quality Assurance
















Core Competencies:



� Teamwork


� Communication skills


� Problem solving




� Flexibility















Key relationships:





Internal


� Formulation Services


� Quality Department


� Manufacturing


� Analytical Services


� Project Manager



Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.


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Please apply with your CV to: Josh Smith