Pharmaceutical Manufacturer and Developer requires an experienced QC Analyst.
About the role:
Directly reporting to the Laboratory Manager, as a successful candidate you will need to have previous experience within a QC laboratory, strong knowledge of HPLC, GC and wet chemistry Techniques.
The candidate needs to be a hardworking and professional team player with strong written and verbal communication skills, experience in a GMP environment & be educated to a good general standard including English and Maths. Excellent attention to detail and organisational skills are essential for this role as is the ability to self-motivate under your own initiative.
You will be required to undertake day to day effective, accurate and efficient processing of workload and to perform tasks assigned by the Laboratory Manager.
Duties may include:
- Achieves competency in Analytical Chemistry laboratory methods and procedures.
Performs routine and non-routine testing activities of raw materials, intermediates, bulk and finished packaged samples in compliance with authorised test procedures using HPLC, GC, IR, UV and Wet chemical techniques.
- Ability to train other QC analysts in laboratory methods and procedures where required.
- Writes and reviews laboratory SOPs and WIs as directed.
- Ensures QC activities are carried out in compliance with cGMP and company quality standards.
- Actively takes part and assists in QC team objectives as required and communicates relevant issues to the Laboratory Manager, anticipates and plans for future requirements in the area.
- Reports non-conformances/ deviations in an accurate and timely manner to the Laboratory Manager
- Deputises for the Laboratory Manager as appropriate.
- May be required to work a shift system in accordance with the operational needs of the business.
- Supports the research and development department with testing activities in relation to method validation and technical transfer activities to ensure that all methods meet ICH, MHRA and EP guidelines.
- Assists (where appropriate) with Operation, maintenance, calibration and troubleshooting of equipment and its associated software.
- Writes, executes, reports and reviews IQ/OQ and PQ protocols (where appropriate) to ensure that all relevant equipment/procedures are qualified for cGMP use.
- Involved in and actively takes part in company improvement projects with knowledge around 5S principles.
Skills and experience:
- Proficiency in applicable GMP regulations.
- Dexterity and attention to detail.
- Ability to train/mentor associates.
- A degree in a scientific/technical discipline OR relevant industry experience.
- A minimum of 2 years' experience in an analytical laboratory testing environment preferably within the pharmaceutical industry.
- Good computer skills particularly in Microsoft Office, Word and Excel
- Experience with GC and their associated software.
- Experience with HPLC and their associated software.
- Experience operating a LIMS system.