quality control specialist - physiochemical.

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 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 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


• - Propose improvements to the area as appropriate and solve problems


• - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance  policies, systems and procedures (COPs, HBR, SOPs and others)

- Master’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar Chemistry, Biochemistry or Health Sciences field
Typically requires 3-5 years of relevant experience in a pharmaceutical QC laboratory environment (mandatory)
Hands-on experience in Analytical Chemistry and QC procedures (mandatory)
Training and experience of GMP and ICH guidelines standards (mandatory)
Knowledge on HPLC and GC, and familiarity with Empower Software (desirable)
Strong understanding and knowledge of GMP practices, analytical theory and techniques
Fluency in English is a requirement
Computer literate with good working knowledge of the MS Office package
Good documentation skills and attention to detail

Integração direta na estrutura do cliente