Job Title:
QC and Stability Chemist
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:
- 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 documentation management system
- Report any Deviations/Out of Specifications to Senior Chemist and complete in a timely manner
- Health & Safety
- Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
- 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.
Other Information
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
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