Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
Rigorously, accurately, efficiently and professionally 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 taking into consideration project demands and requirements
Execute project specific analytical tasks and act as a stakeholder liaison
Provide an example of professionalism and support the induction and training of new colleagues within the area
Ensure that all assigned analytical tasks, including (but not limited to) method development, method creation, method transfer, method validation, protocol preparation and report preparation, in any analytical project is well managed and delivered on time, safely, efficiently, reliably and in a cost-effective manner by performing and planning
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 the effective and proactive flow of information between the Analytical team and the internal and external (if applicable) stakeholders, representing the team as appropriate
Reviews work generated by the team as required ensuring all procedures are followed
Creation, investigation and evaluation of CAPAS, incidents and deviations
Perform equipment maintenance, internal calibrations and internal qualifications on designated laboratory instruments
Accurately use and maintain all laboratory information systems
To maintain good hygiene and housekeeping within the laboratory
To maintain all laboratory records, project and general logbooks and notebooks to an acceptable GLP standard and in accordance with company internal procedures
Fulfil and promote all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities
Be an advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks, discrepancies, deviations or non-conformance in accordance with company internal procedures, suggesting optimizations or improvements
Assist with audits / investigations as required, following the instruction of QC Management
Support the generation / reporting of KPIs for the team, if required
Develop and accumulate strong analytical chemistry expertise, sharing knowledge of new technologies and methodologies within the area
Provide relevant training to other areas in accordance with established training plans
Participate, as required, in the induction and training of new colleagues
Drive high standards in the QC Laboratories
Use analytical techniques and instrumentation, such as gas and high-performance liquid chromatography (HPLC) amongst others
Interpretation of data and analysis to ensure meeting strict guidelines on documentation and recording data
Work collaboratively in cross-functional teams and understand each departments function and role in delivery of tests and products
Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner
Propose improvements to the area as appropriate and solve problems
Make quality and timely decisions within the quality control tasks under her / his responsibility
Gather relevant data to inform the decision makers regarding complex issues
Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of company s policies, systems and procedures (COPs, HBR, SOPs and others)
Undertake any additional tasks commensurate with the role as and when required
Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.