My client, a pharmaceutical company that produces oral solid dosage products, is currently seeking to hire an experienced QC Analyst to join their growing team in Berkshire.
This QC Analyst job will assume responsibilities carrying out Quality Control analysis on Incoming Materials, Components and Products (including stability and other samples) and data to support manufacturing and QC functions.
- Help ensure that QC functions operate in a fully GMP compliant manner and in compliance with the filed regulatory dossiers for the products supported.
- Write, review, approve and implement SOP's, methods, protocols, method/equipment validation, method development/transfer and reports as required.
- Able to follow and have a detailed understanding of specifications for sample analysis.
- Provides technical support/advice and guidance for QC testing to ensure that the test methods are robust and drive improvement of test methods.
- Ensures Stability program operates efficiently and supports product shelf life to meet regulatory requirements
- Participate in documentation, laboratory systems and processes to include updating as required existing.
- Required to be involved in various audits and provide responses to auditors questions for Internal and External audits.
- Experience in identifying out of specification, atypical results and trend.
- Seeks best practice and shares within the team and to a wider audience.
Education and Experience:
- Degree in Chemistry, Pharmaceutical Science, analytical or related
- Proven experience of 1-3 years as QC Analyst.
- Strong hands-on experience of undertaking testing, analysis and development using instrumentational analysis such as HPLC, Dissolution, FTIR and GC.in a cGMP environment.
- Extensive knowledge of GMP, ICH guidelines, BP/EP/USP methods with a strong understanding of QA processes and methodologies.
- Experience of LIMS or equivalent system is desirable
This is a great opportunity to play an influential role within a business and witness the value you will have created to their future growth.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nisha Patel on +44 203 8618 210 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
For more information please get in touch with Nisha Patel on 0203 861 8210 or via email on [click here]