My client, a generics pharmaceutical company in the Berkshire area, is looking for both a QC Analyst and a Senior QC Analyst on a permanent basis. Please find below an overview of the details covering the Senior QC Analyst role but being relevant to the QC Analyst position too.
*The successful candidate will carry out Quality Control analysis on Incoming Materials, Components and Products (including stability and other samples) as well as data in support of onsite manufacturing and all QC functions.
*You will be required to manage your work tasks and promptly report any delays you may incur
*You will be required and be expected to be able to troubleshoot laboratory and software problems.
*The successful candidate will help to ensure that QC functions operate in a fully current GMP manner in compliance with the filed regulatory dossiers for the products supported.
*You will need to be able to review analytical results against specification with accuracy.
*You will partake in the Writing, reviewing and approving of SOPs as well as their methods, protocols, method/equipment validation, method development/transfer and reports implementation in support of analytical duties.
*Able to follow and have a detailed understanding of specifications for sample analysis.
*The successful candidate will need to be able to provide technical support, advice and guidance for QC testing to ensure that the test methods are robust and drive improvement of test methods where necessary.
*Ensure the Stability program operates efficiently and supports product
shelf life to meet regulatory requirements.
*Participate in the documentation of laboratory systems and processes including the updating of existing documentation as required
*You will be expected to foster good relations and communications with fellow Analysts and respond politely and in a timely manner to stakeholder requests.
*You will be responsible in supporting the QC Manager in ensuring all Analysts' training is relevant and up to date- including that of your own
*You will support the QC Manager in coaching and mentoring the Junior QC Analysts as well as the QC Analysts.
*You will be key in maintaining good housekeeping standards within the laboratory, ensuring the laboratory is clean, and has sufficient stock levels of consumables and reagents.
*The successful candidate will have an active role in safety, regulatory, customer and internal audits.
*Experience in identifying out of specification, atypical results and trend.
*Support QC Instrument/ equipment qualification, calibration and servicing programs.
*The successful candidate will always seek best practice process and should share this to all relevant stakeholders.
*Strong understanding of Microsoft Office Products.
*Attention to detail and quality of documentation
*Good interpersonal skills
*Effective oral and written communication skills
*Excellent organizational and planning skills
*Ability to work independently
*Ability to interpret data
*Ability to demonstrate calm objectivity in a pressurised, results driven environment, whilst successfully dealing with often changing and conflicting priorities.
If the above may be of interest please do apply and feel free to get in touch with Ross Wilson at firstname.lastname@example.org or +44(0)1727 817621 to find out further information.