QC Analyst
Maidenhead
Up to £26,000
Permanent employment
An exciting opportunity for a Quality Control Analyst to join an expanding team in a newly established and evolving generic IP focused pharmaceutical company. The successful candidate will be undertaking the testing of materials, components and finished products, gaining a great insight into the business area of Quality.
Responsibilities
• Carry out Quality Control analysis on Incoming Materials, Components and Products (including stability and other samples) as well as data in support of the onsite manufacturing and QC functions
• Help to ensure that QC functions operate in a fully current GMP compliant manner and in compliance with the filed regulatory dossiers for the products supported.
• You will have involvement 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.
• Participate in documentation, laboratory systems and processes to include updating existing ones as required.
• The successful candidate will be involved in various 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 partake in ensuring all housekeeping and work safety operations within the QC laboratory take place in the correct and proper manner
• Any other task given to you by relevant stakeholder in order for you to be able to perform your role
Required Skills
• Degree in Chemistry, Pharmaceutical Science, analytical or related
• Proven experience of at last 1 years QC Analyst.
• Strong hands-on experience of undertaking testing, analysis of Raw Material, Packaging Material and Finished Product using instrumentational analysis such as
o HPLC
o Dissolution
o UV
• Good knowledge of GMP, MHRA and, ICH guidelines, with an understanding of Quality Assurance processes and methodologies.
• Experience of LIMS or equivalent system is desirable.
• Good understanding of FDA guidelines and other governing bodies is desirable but not essential