Overview
Reference Number: JO-2311-526138
Senior QC Analyst
Rate: £30,000 – 33,000
Job Type: Permanent
Location: Maidenhead
Senior QC Analyst
Up to £33,000 depending on experience
Maidenhead
Permanent employment
An exciting opportunity for a Senior Quality Control Analyst with previous experience to join an expanding team of Analysts in a new and evolving generic IP focused pharmaceutical company. The key purpose of this role is to directly support the Quality Control Manager in the smooth and compliant running of the QC department
Responsibilities
• Carry out Quality Control analysis on Incoming Materials, Components and Products (including stability and other samples) as well as data in support of onsite manufacturing and all QC functions.
• Support QC functions in operating in a fully current GMP manner in compliance with the filed regulatory dossiers for the products supported.
• Review analytical results against specification with accuracy.
• Partake in the writing, reviewing, and approving of SOPs as well as their methods, protocols, method/equipment validation, method development/transfer and reports implementation in support of analytical duties.
• Follow and have a detailed understanding of specifications for sample analysis.
• Identify out of specification, atypical results and trends.
• Support QC Instrument/ equipment qualification, calibration and servicing programs.
• Provide technical support, advice and guidance for QC testing to ensure that the test methods are robust and drive improvement of test methods where necessary.
• Ensure the Stability program operates efficiently and supports product shelf life to meet regulatory requirements.
• Participate in the documentation of laboratory systems and processes including the updating of existing documentation as required.
• Support the QC Manager in ensuring all Analysts’ training is relevant and up to date, including that of your own
• Support the QC Manager in coaching and mentoring the Junior QC Analysts as well as the QC Analysts.
• Maintain good housekeeping standards within the laboratory, ensuring the laboratory is clean, and has sufficient stock levels of consumables and reagents.
• Take an active role in safety, regulatory, customer and internal audits.
• Partake in the 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 3-5 years as QC Analyst or 1+ years as a Senior QC Analyst.
• Broad experience in method development and validation
• Experience in equipment qualification, calibration and servicing up to fair level.
• Supervisory experience and the ability to support and motivate team members.
• Strong hands-on experience of undertaking testing, analysis, qualification, troubleshooting and development using instrumentational analysis including:
o Gas chromatography
o Particle Size Analysis
o HPLC
o UV
o Dissolution
o FTIR 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.
• Sound understanding of MHRA guidelines
• Good understanding of FDA guidelines and other governing bodies is desirable but not essential
• Experience in or the ability to learn how to effectively help guide Junior Analysts and Analysts in their development
