Senior Quality Control Analyst
2 weeks ago
This is an exciting opportunity to join a rapidly expanding pharmaceutical company within their Quality Department as a Senior Quality Control Analyst.
With a Quality facility equipped with high-spec instrumentations, an elaborate Wet Lab for chemical analysis and a dedicated Stability Area with temperature and humidity chambers ranging from Zone I to Zone IV b, you would be joining a company with an extensiveportfolio of products which they manufacture and strives to excel in quality, safety, compliance, and performance. This facility is also used to support manufacturing and product development as well as routine testing of raw materials, stability samples, andfinished products.
This role will primarily involve directly supporting the Quality Control Manager to ensure the smooth and compliant running of the QC department. It will also require assisting in mentoring junior analysts.
Key Responsibilities:
- QC analysis on Incoming Materials, Components and Products (including stability and other samples)
- Ensuring that the QC functions operate in compliance with the cGMPs and with the field regulatory dossiers
- Providing technical advice for QC testing while making sure that the methods used are followed correctly and driving improvement of tests methods, if needed
- Participating in the writing, reviewing, and implementing of SOPs, methods, protocols, and reports
- Actively participating in safety, regulatory, customer and internal audits
- Ensuring that all the housekeeping and work safety operations operate in a proper manner within the QC laboratory
Key Requirements:
- Chemistry/Pharmaceutical Science/related degree
- Extensive experience working as a QC Analyst or a Senior QC Analyst
- Extensive experience in testing as well as analysis of Raw Material, Packaging Material, and Finished Product
- Being well-versed with instrumentational analysis, including HPLC, Dissolution, UV, Gas chromatography, Particle Size Analysis, and FTIR in a cGMP environment
- Robust understanding of GMP, MHRA and ICH guidelines as well as BP/EP/USP methods with a strong understanding of QA processes and methodologies
- Ability to help guide Junior Analysts and Analysts in their development
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