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TPM02948 - QC & Stability Chemist

Company:
Tandem Project Management Ltd.
Location:
Waterford, Country: Ireland
Job Type:
full-time, permanent
Job Description

Summary:
A QC & Stability Chemist is required for a pharmaceutical company in Waterford. The successful candidate will support QC and Stability by ensuring all raw materials, packaging, finished products and Stability samples are analysed in accordance with cGxP.

Responsibilities:

  • Test and complete write up of QC raw material, packaging, finished product and stability samples in a timely & efficient manner.
  • Support all other on-going laboratory functions & requirements.
  • Prepare and review stability summary sheets where required.
  • 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.
  • 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 the documentation management system.
  • Report any Deviations/Out of Specifications to Senior Chemist and complete in a timely manner.
  • Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs.
  • Report any defects.
  • Reports directly to the QC/Stability Team Leaders.

Qualifications & Experience:

  • Qualified to a minimum of honours degree level in Analytical Chemistry, Pharmaceutical science or related discipline.
  • 2 years’ experience working in a related technical environment is preferable but not essential.
  • 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.
  • Broad understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions.

Job Types: Full-time, Permanent

Job Settings
Number of jobs: 1 hires
Information about the advertiser
Company: Tandem Project Management Ltd.
Company size: 1-49
Contact: NA