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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