Technical Scientist - Method Development and Validation
Location: Wrecsam Wales
Description: Pulse Staffing UK is looking of Technical Scientist - Method Development and Validation right now, this career will be placed in Wales. For complete informations about this career opportunity kindly read the description below. Technical Scientist Method Development and Validation North Wales £20,000-£24,000
My Client is an established pharmaceutical development company, working on the cutting edge of pharmaceutical science. A new position has become available within their industrialisation group for an experience analytical chemist with method development and validation experience.
The main responsibilities of the role would be:
- To assist in the provision of non routine support for processes/methods and the development of new/novel methods to support process, transfer and improvement activities.
- Work with third parties in order to progress Industrialisation Group activities.
- Perform experimentation to support Industrialisation Group activities, collate the data and write technical reports
- To use TrackWise as a tool to progress changes related to Industrialisation Group activities
- Ensure that experimental work is recorded in appropriately controlled laboratory books or protocols in accordance with the requirements of GxP
- Prepare URSs for laboratory equipment and prepare and execute the subsequent IQ/OQ of the equipment
- Manage consumable inventory levels within the laboratory and ensure that equipment maintenance and calibration is performed in line with approved procedures.
- Operate equipment in a safe manner and in accordance with cGXP and Heath & Safety guidelines. Report defective equipment and ensure it is repaired.
- Prepare SOPs for processes/methods, assist in the preparation of Training Packages, and perform training.
- To assist in the development of new assays, including microbiological, and their subsequent validation for use in routine QC testing
- To draft and execute validation protocols for new assays and input into decisions on validation and acceptance criteria, assay system suitability criteria and capability expectations
- To support investigations into routine assay problems
- To become familiar with new methods to ensure robust development and validation
- To assist in the periodic review of assays to ensure they are still fit for purpose
- To assist in the generation of data in support of regulatory submissions and responses to questions received from regulatory agencies
- You are responsible for familiarizing yourself with the Company EHS policies and procedures and ensuring that all rules and regulations are followed within your areas of work to ensure a safe working environment.
- You must highlight with your line manager any difficulties or misunderstanding or deficiencies in any SOPs Work plans etc that may give rise to a work place risk.
- You must ensure that all hazards, incidents and accidents are reported to your line manager and liaise with your departmental EHS Rep and EHS department to improve environmental and health and safety matters within your work areas.
- To provide ongoing management of fully functional and compliant subsystems and associated staff that are integral to the site Quality management system. Other activities include contribution to Quality processes/initiatives at a local and Global level where required. To follow and assist in the implementation of GMP/GCLP standards which contribute to the company and site objectives
To apply for this position please send your CV to Brendan Rogers at PULSE Life Sciences.
- .
If you were eligible to this career, please email us your resume, with salary requirements and a resume to Pulse Staffing UK.
If you interested on this career just click on the Apply button, you will be redirected to the official website
This career starts available on: Fri, 24 Aug 2012 01:30:34 GMT
Apply Technical Scientist - Method Development and Validation Here