We have an immediate opportunity with long established multinational pharma client for QC Analyst to join their team on 6 months contract.
JOB PURPOSE:
To perform the duties listed below in carrying out the analysis function in the QC Department according to standard procedures.
• Perform analysis using a wide range of equipment and to carry out water sampling and analysis when required
• Ensure all standards/reagents are used as per procedures.
• Responsible for completion of QC work schedule and daily review with QC Team leader
• Responsible for maintaining sample storage in a manner that ensures compliance to FDA and IMB standards
• Responsible for pre-shipping inspection of shipments and approval prior to dispatch when required
• To carry out special projects e.g. Method Transfer, in a timely and accurate manner and to report and file results in accordance with SOP and external requirements
• Continuously liaise with production regarding in-process control analysis to ensure the completion of analysis in a timely manner and accurate transfer of information from laboratory to production
• To develop and validate new analytical methods (including cleaning validation and recovery studies) as required for use in Quality Control
• Transfer externally originating analytical methods to Quality Control.
• Assist in the training of personnel when required
• To maintain and calibrate analytical test equipment as per the QC maintenance and calibration schedule and in line with site procedures.
• To ensure all new equipment is appropriately qualified and the supporting documentation completed before introduction into the QC laboratory
• To maintain and provide support for laboratory software systems to CFR 21 part II standard.
• Reviewing and filing of Finished Product, Raw Material, Stability and EDAS paperwork on a routine basis
• Compile Annual Product Reviews as requested by QC management
• Review and update of analytical methods and SOPs as required
• Participate in the departments Continuous Improvement initiatives, including but not limited to updating and input of data into Cycle Time Tracker and Key Metric Tracker spreadsheets
• Plan sampling requirements with regard to raw materials, APIs and materials for retest.
• Perform sampling of raw materials / finished products when required as per standard procedures.
• Liaise with internal / external customers regarding technical requests e.g. samples, Certificates of Analysis, etc.
• Organise samples to be sent for external analysis e.g. micro samples.
• Maintain control of reference standards in accordance with department SOPs.
• To carry out all activities in a manner that is concordant with GMP and procedures
• To maintain your workplace and area of work in a clean and tidy condition during and after any work completion. (i.e. clean as you go)
• To ensure that all waste is disposed of as per our Licence requirements, correctly segregated and materials stored in a correct manner.
• To ensure unsafe and potentially non-compliant environmental conditions are proactively identified and resolved.
• To keep an energy and cost aware focus and to work to reduce energy usage and waste on site.
• Any other reasonable job related duties that may be required from time to time.
QUALIFICATIONS:
• Diploma in Chemistry or equivalent
SKILLS:
• Ability to work well with others in a team environment
• Excellent communication and problem solving skills
• Good Organisational skills
EXPERIENCE:
• Previous experience within the pharmaceutical industry in a similar role in a QC laboratory desirable but not essential
• Experience in running, upkeep and maintenance of standard laboratory equipment
• Familiarity with analytical development and validation desirable
KNOWLEDGE:
• Knowledge of regulatory and legislative requirements.
• Knowledge of company policies and procedures
eFlexes is an equal opportunities employer
