QA Specialist

  • Location

    Oxfordshire

  • Sector:

    Pharmaceutical

  • Job type:

    Permanent

  • Salary:

    Excellent

  • Contact:

    Peter Rowland

  • Contact email:

    peter@rowlandtalent.co.uk

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    RT106

  • Published:

    almost 2 years ago

  • Expiry date:

    2018-02-20

  • Startdate:

    ASAP

Rowland Talent Solutions has an excellent opportunity for a QA Specialist for an R&D Pharmaceutical company in Oxfordshire.

As a QA Specialist you will help maintain the site’s Quality Management System (QMS) supporting the cGMP manufacture of Pharmaceutical products at various batch sizes.

Responsibilities:

  • Writing and reviewing manufacturing batch records (BMRs), cleaning documentation and associated analytical data.
  • Provide Quality expertise to the site including the assurance of facility and equipment calibration and maintenance, and provide technical GMP support to the Production and Analytical departments and Clients as required.
  • Conduct internal audits.
  • Participate in GMP training of personnel involved in manufacturing and conduct GMP compliance projects across the site.
  • Identify issues and participate in the investigation of problems to identify root causes associated with deviations and OOS investigations. Work with the GMP operators/ Managers to find resolutions to any non-conformances identified.
  • Aid in the identification of inefficient processes and introduction of lean alternatives whilst maintaining compliance
  • Administration of the site’s GMP systems and processes

 

Ideal candidates will be degree qualified in Chemistry and have previous experience of working in a Pharmaceutical CMO environment working to cGMP. You will have experience with Quality Management Systems and quality programs such as cGMP/ICH Q7, and maintenance of cGMP compliance.

It is desirable that candidates have experience in reviewing batch records in a chemical or Pharmaceutical manufacturing plant.

 

 

Key words: BMRs, QA Officer, Quality Assurance, Audits, CAPA, Deviations, QMS, SOPs, OOS, GMP