Job Title: QC Analyst- Micronised Lab
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 micronised API including Particle Size Analysis (PSA) and HPLC for assay and impurities.
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 appropriat
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 micronised API including Particle Size Analysis (PSA) wet and dry technics on MS 2000, MS3000 and Sympatec Helos equipment and 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.
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy