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Development Analyst – Level 2

Job Title: Development Analyst – Level 2
Location: Tredegar
Department: Analytical Development
Reporting to: AS Team Leader
Responsible for (staff): N/A

General Purpose of Role:

  • To perform the Analytical testing function in an efficient and effective manner in full compliance with relevant documented procedures and pertinent regulatory/company requirements.

Main Responsibilities:

  • To perform routine laboratory procedures right first time with minimal personal OOS results and if relevant and instructed to do so, to assist others within the team.
  • To plan and prioritise own day to day workload in line with client requirements and adapt this where necessary in line with client needs and expectations.
  • To assist in preparation of technical documentation within the Department, as required.
  • To assist in training of others, as required.
  • To ensure that all work carried out complies with departmental procedures and is cGMP compliant
  • To ensure that all personal lead times are complied with, subject to the absence of attenuating circumstances.
  • To assist in the performance of project work within the team, as required.
  • To assist in the development and validation of laboratory procedures within the team, as required.
  • To review analytical and laboratory data within the team for accuracy, completeness and compliance with documented procedures.
  • To communicate effectively with others on site and to assist with departmental problem solving as required.
  • To ensure that all health and safety procedures are adhered to with respect to personal duties and the duties of others.
  • To undertake other laboratory and business related tasks as and when required to meet department and business needs and within the scope of the job-holder’s capabilities and responsibilities.
  • To undertake such tasks and to manage specific internal or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities and responsibilities.
  • Self-motivated to gain additional pharmaceutical Development Knowledge.
  • Actively seeks and demonstrates to perform tasks for the department outside of set analysis activities.

Regulatory/Industry Responsibilities:

General

  • The job holder is responsible for adhering to PCI SOPs, Health & Safety, GMP and other regulatory guidelines.

GMP Requirements Hierarchy

  • GMP Skill Level 1 is essential for this role.
    (further information regarding GMP Requirements Hierarchy, can be obtained at SOP-L&D-001)

Specific Qualifications:

  • A degree in a scientific subject as a minimum (preferably Chemistry).
  • UK Driver’s License / access to transport

Previous Work Experience:

  • Previous laboratory and analytical experience essential (minimum 1 year), preferably in a pharmaceutical environment.
  • Practical HPLC usage
  • Method Validation Experience
  • Familiar with lab systems such as Empower

Specific Knowledge / Skills Competence:

  • GMP
  • HPLC Theory
  • Method Validation
  • ICH guidelines
  • Regulatory bodies
  • Good communication skills
  • Good Time management

Behavioural Competencies:

  • Honest and trustworthy
  • Customer focussed
  • Self-motivated and pro-active
  • Conscientious
  • Team Player
  • Organised

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