Responsibilities
Reporting to the QC Chemistry Supervisor, the person will be responsible for the following;
- Performing a wide variety of analytical chemistry testing to support utilities, raw material, in process and bulk drug substance release.
- Undertaking HPLC & UPLC analysis on in process and bulk drug substance samples
- Ensures that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
- Completes own test records on time and peer reviews data from other analysts for accuracy and completeness.
- Maintains laboratory reagents and supplies.
- Calibration of laboratory instruments.
- Participates in the method transfer activities from other test facilities.
- Provides support and advice to manufacturing on QC related topics.
- Conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
- Initiates and completes CAPAs and Change Controls in accordance with site procedure.
- Writes new and updates current SOPs as needed.
- Provides training to other analysts in the QC group.
- Presents analytical data reports clearly and concisely to management.
- Proactively identifies and implements lab process improvements, lean initiatives.
- Performs other duties relevant to the QC laboratory position as required.
Requirements
- A third level qualification in a scientific/technical discipline.
- At least 2+ year hands-on work experience in a regulated QC laboratory-testing environment within the biopharmaceutical/pharmaceutical industry.
- Experience in HPLC & UPLC analysis
- Excellent Communication skills, both verbal & written.
- Experience with electronic systems such as LIMS, Empower, SoftMax, Qumas, eDoc, Trackwise etc., is an advantage.
- Adaptable and flexible, willing to travel when needed.
- Collaboration and team work. Maintains the highest standards of ethical behaviour.
- Results and performance driven.
- Strong analytical ability and associated problem solving.
- Good time management and attention to detail.
- Knowledge and proficient in the use of Microsoft products including, Excel, Word and Powerpoint.
Preferred Laboratory Experience in one or more of the following areas
- Familiar with USP, JP and EP methodology
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