An excellent opportunity has arisen for a QC Analyst to join a growing organization based in Maidenhead, Berkshire.
*Execute Quality Control analysis on Incoming Materials, Components and Products (including stability and other samples) alongside data in support of the onsite manufacturing and QC functions
*Assist in making sure that QC functions operate in a fully current GMP compliant manner and in compliance with the filed regulatory dossiers for the products supported.
*Participating in the writing, reviewing and implementing of SOP's, methods, protocols and reports as required.
*You must be able to follow and understand specifications for sample analysis.
*The successful candidate will need to be able to provide technical support/advice for QC testing whilst ensuring that the test methods are followed correctly.
*Assisting with documentation, laboratory systems and processes to include updating existing ones as required.
*The successful candidate will be involved in a range of audits as and when required.
*You will need experience in identifying out of specification as well as atypical results and trends.
*The successful candidate will always seek best practice process and should share this to all relevant stakeholders.
*You will be expected to make sure all housekeeping and work safety operations within the QC laboratory take place in the correct way
*Any other task given to you by relevant stakeholder in order for you to be
able to perform your role
*Degree in Chemistry, Pharmaceutical Science, analytical or related
*Proven experience of 2-4 years as QC Analyst.
*Strong hands-on experience of undertaking testing, analysis and development using instrumentational analysis such as:
- FTIR in a cGMP environment.
*Good knowledge of GMP, ICH guidelines, BP/EP/USP methods with an understanding of QA processes and methodologies.
*Experience of LIMS or equivalent system is desirable.
*Sound understanding of MHRA guidelines
*Good understanding of FDA guidelines and other governing bodies is desirable but not essential
*Strong Microsoft Office Suite experience.
*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.
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email email@example.com