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Quality Control Specialist

2 months ago

Ware, Hertfordshire, United Kingdom SRG Full time
Job Title: Quality Control Specialist - Respiratory

Location: UK

Salary: £27-28.5K p/a

Contract: 12 month FTC

About the Role:

We are seeking a highly skilled Quality Control Specialist to join our team at SRG, a world-leading pharmaceutical organisation. As a Quality Control Specialist, you will play a critical role in ensuring the quality and compliance of our medicinal products.

Key Responsibilities:

  • Operational:
    • Perform analysis of samples and support technical investigations/monitoring, using a range of analytical techniques related to the testing of finish drug products.
    • Prepare and check analytical data accurately according to company, customer, and regulatory requirements.
    • Assess the quality and accuracy of analytical results and determine if material meets pre-defined acceptance criteria.
    • Undertake analysis as required to support process investigations or as part of process qualification and validation exercises.
    • Responsible for assigned items of Laboratory equipment or 5S standards.
    • Responsible for the safety of self and others within the Laboratory.
  • Customer:
    • Analyse samples according to pre-defined test methods, specifications, or Pharmacopoeia.
    • Ensure analytical records follow ALCOA principles (attributable, legible, contemporaneously recorded, original, and accurate).
  • Compliance:
    • Responsible for ensuring that Laboratory work areas maintain high standards of housekeeping and meet requirements such as 5S.
    • Responsible for maintenance and calibration of Laboratory equipment as assigned by Laboratory Team Leader.
    • Responsible for ensuring equipment used is calibrated, validated, and fit for use. Deficiencies are resolved promptly in consultation with the responsible person or expert user.
    • Analysis is undertaken safely and compliantly, meeting all required standards of EHS legislation and GMP, such as COSHH, Risk Assessments, and DSE.
    • Responsible for documenting and communicating Laboratory issues, such as safety, compliance, and analytical issues giving rise to invalid data.
    • Ensure sample solutions, standards, and test media are used within expiry dates, or re-evaluated as appropriate.
  • People:
    • Takes responsibility for own training and development. Maintains up-to-date training records, as well as performance and development plans.
    • Provides training in areas of expertise, such as the use of analytical equipment to fellow Analysts.
    • Proactively provides feedback on the quality and effectiveness of training as it is received.
    • Maintains analytical knowledge and access to systems ensuring they are up to date for all relevant equipment and techniques and seeks refresher training as required.
  • New Products:
    • May participate in method transfers and new product introduction exercises, for example, trialing new technology and methodology, providing feedback to Laboratory Team Leader and other staff.

Requirements:

  • Relevant Science Degree (for example Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Forensics) or equivalent, with up to 1- or 2-years practical work experience.
  • Experienced in QC testing of finish drug products including HPLC for assay and impurities.
  • Is proficient in the use of numerous Laboratory instruments, software packages, and other analytical techniques (E.g. Empower 3).
  • Is proficient in problem-solving and may have expertise in troubleshooting analytical equipment.
  • Is competent in application of statistical and mathematical tools and formulae.
  • Understands purpose of all techniques applicable to dosage form.
  • Is aware of relevant national/international Pharmaceutical regulatory authorities.
  • Competent in the use of corporate IT systems.
  • Is computer literate and competent in the use of Microsoft packages.
  • Effective verbal and written communication skills.
  • Enthusiasm to work in a laboratory-based role.