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Quality Control Analyst

Pharmaceutical

Berkshire (£) Competitive
permanent Job Ref: 6132

Description

A Pharmaceutical company focusing on solid dosage generic pharmaceuticals is looking for a Quality Control Analyst to join its growing team. You will be responsible for the testing of materials components and finished products. You must hold a degree in chemistry or related discipline and have significant QC experience in a GMP environment to apply for this role.

Responsibilities

  • Carry out Quality Control analysis on Incoming Materials Components and Products (including stability and other samples) as well as data in support of the onsite manufacturing and QC functions
  • Help to ensure that QC functions operate in a fully current GMP compliant manner and in compliance with the filed regulatory dossiers for the products supported.
  • You will have involvement in the writing reviewing and implementing of SOP’s methods protocols and reports as required.
  • You must be able to follow and understand specifications for sample analysis.
  • The successful candidate will need to be able to provide technical support/advice for QC testing whilst ensuring that the test methods are followed correctly.
  • Participate in documentation laboratory systems and processes to include updating existing ones as required.
  • The successful candidate will be involved in various audits as and when required.
  • You will need experience in identifying out of specification as well as atypical results and trends.
  • The successful candidate will always seek best practice process and should share this to all relevant stakeholders.
  • You will be expected to partake in ensuring all housekeeping and work safety operations within the QC laboratory take place in the correct and proper manner
  • Any other task given to you by relevant stakeholder in order for you to be able to perform your role

Required Skills

  • Degree in Chemistry Pharmaceutical Science analytical or related
  • Proven experience of 2-4 years as QC Analyst.
  • Strong hands-on experience of undertaking testing analysis and development using instrumentational analysis such as
    • HPLC
    • GC
    • Dissolution
    • UV
    • FTIR in a cGMP environment.
  • Good knowledge of GMP ICH guidelines BP/EP/USP methods with an understanding of QA processes and methodologies.
  • Experience of LIMS or equivalent system is desirable.
  • Sound understanding of MHRA guidelines
  • Good understanding of FDA guidelines and other governing bodies is desirable but not essential

This is a great opportunity to join an expanding business and gain insight into the development of an emerging pharmaceutical company.

Competitive salary in line with experience

Job Ref: 6132