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.
Required Skills
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
HPLC
GC
Dissolution
UV
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
Please contact Liam Smith at Science Solutions