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Quality Control Analyst

2 months ago

Ware Hertfordshire, United Kingdom SRG Full time €27,000 - €28,500

Job Title: QC Analyst– Respiratory

Location: Ware, UK

Salary: £27-28.5K p/a

Contract: 12 month FTC

SRG is currently working with a world-leading pharmaceutical organisation located in Ware with a vacancy for a QC Analyst.

Core responsibilities:

Support the Quality Assurance Department in ensuring that all aspects of the manufacture of medicinal products are performed in controlled manner and meet commitments to international regulatory bodies as well as the requirements of current Good Manufacturing Practice. The laboratory teams working as part of the Site Value Streams will assure that manufactured products are compliant and fit for purpose.

Principal accountabilities:

  • Performs analysis of samples and supports technical investigations/ monitoring, using a range of analytical techniques related to the testing of finish drug products including HPLC, for assay and impurities, NGI, AED, BCU and method troubleshooting.
  • Prepares and checks analytical data accurately according to company, customer and regulatory requirements.
  • Assesses the quality and accuracy of analytical results and determines if material meets pre-defined acceptance criteria.
  • Undertakes analysis as required to support process investigations or as part of process qualification and validation exercises.
  • Is responsible for assigned items of Laboratory equipment or 5S standards.
  • Responsible for the safety of self and others within the Laboratory.
  • Analyses samples according to pre-defined test methods, specifications or Pharmacopoeia. Ensures analytical records follow ALCOA principles (attributable, legible, contemporaneously recorded, original and accurate)
  • 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.
  • Ensures sample solutions, standards and test media are used within expiry dates, or re-evaluated as appropriate
  • Has awareness of change control processes and need to control changes.
  • 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.
  • 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.

Qualification and Experience:

  • 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.