Quality Assurance Specialis - Loures - Sete Casas

Descrição: 

We are hiring a Quality Assurance Specialis for a company in the pharmaceutical industry.

O que terás de fazer

- Apply and develop knowledge of Quality Control and participate in area processes, procedures and projects with the guidance of more senior colleagues

- 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 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 (with support from senior colleagues) 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 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 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) 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

- Perform to ensure all assigned tasks are delivered on time, safely, efficiently, reliably and in a cost-effective manner

- 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).

- 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

O que precisas de garantir

- University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field (mandatory);

- Typically requires 3-5 years of relevant experience in a QA GMP environment within the Pharmaceutical Industry (highly desirable);

- Experience of working in a GMP operational environment (mandatory);

- Training and experience of GMP standards (mandatory);

- Experience of working with Regulatory Affairs and a basic knowledge of the function (desirable);

- Strong understanding and knowledge of GMP practices;

- Fluency in English is a requirement;

- Computer literate with good working knowledge of the MS Office package;

- Strong documentation skills and attention to detail.

O que te proporcionamos

- Salary compatible with function.

O que terás de fazer

- Apply and develop knowledge of Quality Control and participate in area processes, procedures and projects with the guidance of more senior colleagues

- 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 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 (with support from senior colleagues) 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 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 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) 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

- Perform to ensure all assigned tasks are delivered on time, safely, efficiently, reliably and in a cost-effective manner

- 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).

- 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

O que precisas de garantir

- University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar scientific field (mandatory);

- Typically requires 3-5 years of relevant experience in a QA GMP environment within the Pharmaceutical Industry (highly desirable);

- Experience of working in a GMP operational environment (mandatory);

- Training and experience of GMP standards (mandatory);

- Experience of working with Regulatory Affairs and a basic knowledge of the function (desirable);

- Strong understanding and knowledge of GMP practices;

- Fluency in English is a requirement;

- Computer literate with good working knowledge of the MS Office package;

- Strong documentation skills and attention to detail.

O que te proporcionamos

- Salary compatible with function.