QC And Stability Chemist

ICDS Recruitment

Waterford

QC and Stability Chemist. Co. Waterford. Job Purpose: To support QC and Stability by ensuring all raw materials, packaging, finished products and Stability samples are analysed in accordance with cGxP. Responsibilities: 1 To test and complete write up of QC raw material, packaging, finished product and stability samples in a timely & efficient manner. 2. To support all other on-going laboratory functions & requirements. 3. To prepare and review stability summary sheets where required. 4.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. 5. To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement. 6. Check own work and that of others for accuracy. 7. To assist in the preparation for internal / customer/ regulatory inspections. 8. Involved in internal investigations e.g. Out of Specifications, Incidents & Deviation investigations etc. 9. Draft, review or revise documentation within EirGen documentation management system. 10. Report any Deviations/Out of Specifications to Senior Chemist and complete in a timely manner. 11. Health & Safety: a. Implement safety as per site documentation including SOPs, Safety Statement and COPs. b. 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, Competencies, Teamwork & Collaboration. Proficient in the use of HPLC & associated problem solving. Proficient with Dissolution testing. Strong analytical ability abilities. Quality Orientation. Knowledge & proficiency of Microsoft products including, Excel, Word and Powerpoint. Time management. Strong attention to detail is critical. 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. This job originally appeared on RecruitIreland.com.

2041 days ago