We are hiring a Quality Control Reviewer for a company in the pharmaceutical industry.
Responsibilities: Apply and develop knowledge of Quality Control and participate in area processes, procedures, and projects with the guidance of more senior colleagues.
Manage, execute, and support all assigned projects in accordance with applicable GMP, quality operational standards/procedures, and legal regulations, escalating as appropriate.
Propose new methodologies considering project demands and requirements.
Execute project-specific analytical tasks and act as a stakeholder liaison.
Support the induction of new colleagues within the area.
Ensure that 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, safely, efficiently, reliably, and in a cost-effective manner.
Solve analytical problems relating to assigned projects by providing collaborative and timely support to all areas and departments, initiating the problem-solving escalation process when unable to solve occurrences within the established period.
Ensure effective and proactive flow of information between the Analytical team and internal and external stakeholders, representing the team as appropriate.
Review work generated by the team as required, 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, project and general logbooks, and notebooks to an acceptable GLP standard and in accordance with internal procedures.
Fulfill and promote all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities.
Advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks, discrepancies, deviations, or non-conformance in accordance with internal procedures, suggesting optimizations or improvements.
Assist with audits/investigations as required, following the instruction of QC Management.
Support the reporting of KPIs for the team, if required.
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), among others.
Interpret data and analysis to ensure meeting strict guidelines on documentation and recording data.
Work collaboratively in cross-functional teams and understand each department's function and role in the delivery of tests and products.
Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements, and promote the implementation and maintenance of systems and procedures (COPs, HBR, SOPs, and others).
Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and comply with environmental, health & safety rules/procedures, regulations, and codes of practice.
Minimum Requirements: University or equivalent qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a similar Chemistry, Biochemistry, or Health Sciences field (mandatory).
Requires 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 of 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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