Associate Analytical Data Reviewer
2 semanas atrás
We are hiring an Associate Analytical Data Reviewer for a leading company in the pharmaceutical industry. If you have a strong attention to detail and experience in reviewing analytical data, this is your chance to contribute to critical processes in a dynamic and growing sector.
Responsibilities:Responsible for data from chemical analyses such as HPLC, GC, DSC, XRPD, PSD;Rigorously manage, execute and support all assigned projects in accordance with applicable GMP, quality operational standards / procedures and legal regulations;Propose new methodologies considering project demands and requirements;Execute project specific analytical tasks and act as a stakeholder liaison;Ensure all assigned analytical tasks, including method development, method creation, method transfer, method validation, protocol preparation and report preparation, are well managed and delivered on time;Solve analytical problems relating to assigned projects by providing collaborative and timely support;Ensure effective and proactive flow of information between the Analytical team and stakeholders;Review work generated by the team, ensuring all procedures are followed;Create, investigate and evaluate CAPAs, incidents and deviations;Perform equipment maintenance, internal calibrations and internal qualifications on designated laboratory instruments;Accurately use and maintain all laboratory information systems;Maintain good hygiene and housekeeping within the laboratory;Maintain all laboratory records to an acceptable GLP standard;Fulfil and promote all applicable GMP requirements and HSE regulations;Be an advocate for safe operating and high-quality performance;Assist with audits / investigations as required;Support the reporting of KPIs for the team;Develop and accumulate strong analytical chemistry expertise;Maintain high standards in the QC Laboratories;Use analytical techniques and instrumentation, such as gas and high-performance liquid chromatography (HPLC);Interpret data and analysis to ensure strict guidelines on documentation and recording data are met;Work collaboratively in cross-functional teams;Execute professional activities in compliance with GMP and HSE guidelines;Carry out assigned tasks in a safe manner, in accordance with instructions.Minimum Requirements:University or equivalent qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar field (mandatory);Educational / training experience in a QC laboratory environment;Hands-on experience in Analytical Chemistry and QC procedures (desirable);Training and experience of GMP and ICH guidelines standards (desirable);Knowledge on HPLC and GC, and familiarity with Empower Software (desirable);Technical understanding of GMP practices, analytical theory and techniques;Documentation skills and attention to detail - Fluency in English is a requirement;Computer literate with good working knowledge of the MS Office package.
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