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Pharmaceutical Development Analyst

Location County Down, Northern Ireland
Sector
Job type Permanent
Salary £30000 - £45000 per annum
Published about 2 months ago
Contact Glenda Reddington
Job ref Pharma Dev analyst_1599748807

Job description

Pharmaceutical Development Analyst

Location: County Down

Salary: Competitive

Working alongside a growing company who are seeking to add to their R&D department. The successful candidate will be responsible for performing chemical and physical testing of new products.

Tasks:

  • Ensure you have the skills set necessary to operate within the required competency level as per key skills matrix.
  • The development, optimisation, validation and transfer of finished products methods of analysis using a range physico-chemical techniques in accordance with the relevant standard operating procedures and regulatory guidelines and requirements.
  • To perform qualification and characterisation of analytical reference standards and associated impurities.
  • To carry out analytical work in support of reverse engineering.
  • To assist in the collection of analytical samples from the production suites in support of development/pre-approval and process validation batches.
  • To assist in trending of analytical data and in investigating out of specification results in accordance with company procedures.
  • Ensure all work is executed in accordance with Methods of Analysis, SOPs, protocols, and
  • GMP where required. To adopt a GMP approach at all times be mindful of data integrity requirements when executing analysis and the corresponding recording of data.
  • The generation, interpretation and recording of data, results, draft methods, protocols and reports pertaining to Method development, validation and transfer alongside stability studies and process validation of the finished product.
  • Ability to actively problem solve, troubleshoot and provide solutions to analytical challenges during testing of finished product methods.
  • Conducting departmental training in all validated finished product methods as part of the method transfer process.
  • Calibration of relevant Laboratory equipment daily.
  • Ensuring the general H&S, cleanliness and tidiness of workplace and laboratory.
  • Training or assisting in training new or existing personnel in laboratory techniques.

Essential Criteria:

  • Educated to degree level in a science-related discipline.
  • Previous experience working in a cGMP environment.
  • HPLC, UPLC, GC and practical wet chemistry experience.
  • Knowledge of VICH guidance for Method Validation of Finished product methods and
  • Stability studies.

Desirable Criteria:

  • Educated in chemistry-related degree subject.
  • Mass spectrometry experience.
  • At least one-year lab experience in a GMP laboratory.
  • Previous Analytical Method Development and Validation experience.
  • Finished product stability study experience.
  • Experience with troubleshooting relevant lab equipment; HPLC, UPLC, GC etc.

To be considered for this position, please forward your CV to glenda.reddington@staffline.co.uk OR call on 02890 323333 EXT: 410

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