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QC and Stability Chemist

  • Salary: Negotiable
  • Job type: Permanent
  • Location:
  • Sector: Other
  • Date posted: 27/08/2018
  • Job reference: BBBH13686

QC and Stability Chemist

Job description:

To support QC and Stability by ensuring all raw materials, packaging, finished products and Stability samples are analysed in accordance with cGxP.

  • To test and complete write up of QC raw material, packaging, finished product and stability samples in a timely & efficient manner.
  • To support all other on-going laboratory functions & requirements.
  • To prepare and review stability summary sheets where required.
  • To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • Check own work and that of others for accuracy.
  • To assist in the preparation for internal / customer/ regulatory inspections.
  • Involved in internal investigations e.g. Out of Specifications, Incidents & Deviation investigations etc
  • Draft, review or revise documentation within EirGen documentation management system
  • Report any Deviations/Out of Specifications to Senior Chemist and complete in a timely manner
  • Health & Safety
  1. Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
  2. Report any defects

Minimum Qualifications & Experience:

  • Qualified to a minimum of honours degree level in Analytical Chemistry, Pharmaceutical science or related discipline.
  • At least two years experience working in a related technical environment is preferable but not essential.

Skills & Behavioural Competencies:

Skills, Competencies, Teamwork & Collaboration

  • Proficient in the use of HPLC & associated problem solving
  • Proficient with Dissolution testing
  • Strong analytical ability
  • Quality Orientation
  • Knowledge & proficiency of Microsoft products including, Excel, Word & Powerpoint.
  • Time management
  • Strong attention to detail is critical
  • Demonstrable problem solving abilities
  • Excellent organisational skills
  • Ability to multitask & work under pressure, coping with more than one conflicting task at once.
  • Excellent Communication skills, both verbal & written
  • Adaptability - maintain effectiveness in varying environments and with different tasks, responsibilities and people
  • Broad understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions
  • Analysis - secure relevant information and identify key issues and relationships from a base of information; relate and compare data from different sources, identifying cause-effect relationships.
  • Working effectively with team or those outside the formal line of authority to accomplish organisational goals; taking actions that respect the needs and contributions of others, subordinating own objectives to the objectives of the organisation.
  • Making efforts to listen and understand the customer (both internal and external); anticipating and providing solutions to customers needs; giving high priority to customer satisfaction.
  • Self starter
  • Safety Awareness
  • Reports directly to the QC/Stability Team Leaders