A Pharmaceutical company focusing on solid dosage generic pharmaceuticals is looking for a Quality Control Analyst to join its growing team. You will be responsible for the testing of materials components and finished products. You must hold a degree in chemistry or related discipline and have significant QC experience in a GMP environment to apply for this role.
- 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
- 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
This is a great opportunity to join an expanding business and gain insight into the development of an emerging pharmaceutical company.
Competitive salary in line with experience
Job Ref: 6132