Quality Systems Specialist - Loures - Sete Casas

Descrição: 

We are hiring a  Quality Systems Specialist for a company in the pharmaceutical industry.

O que terás de fazer

 - Promote high-quality work within the team and a mindset of continuous improvement;

- Advise Team Members when unconformities with Quality or, Regulatory Systems and Tools have been identified and promote corrective actions;

- Propose new procedures and or policies according to the requirements applicable to the company business and strategy and review existing procedures;

- Prepare Quality and/or Regulatory Systems and Tools related documentation and training;

- Participate in Audits/inspections (Internal and of Health Authorities);

- Perform other Corporate key activities, such as delivering Corporate Quality or Regulatory KPI’s, Corporate Quality or Regulatory Training, Quality and/or Regulatory Systems Management (e.g., Documentation Management System), CAPA, Change Control, corporate analytical electronic systems, filings, customer support etc.);

- 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;

- Lead initiatives within group or department, ensuring plan definition and timely execution;

- Make quality and timely decisions within the Quality and/or Regulatory Systems’ tasks under her / his responsibility;

- Gather relevant data to inform the decision makers regarding complex issues;

- 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;

- Execute professional activities in compliance with applicable Quality, Regulatory 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) May qualify as internal GMP auditor.

O que precisas de garantir

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

- Typically requires 3-5 years of relevant experience in operational areas (e.g., Quality Control, Quality Assurance, Manufacturing, R&D, Engineering), preferably within the Pharmaceutical Industry;

- Strong understanding and knowledge of Quality and/or Regulatory requirements, cGMP´s, ICH, CFR, EU, local or any other as applicable guidelines and ISO Standards as applicable with the ability to solve complex problems;

- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down;

- Fluency in English is a requirement;

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

O que te proporcionamos

- Salary compatible with function;

O que terás de fazer

 - Promote high-quality work within the team and a mindset of continuous improvement;

- Advise Team Members when unconformities with Quality or, Regulatory Systems and Tools have been identified and promote corrective actions;

- Propose new procedures and or policies according to the requirements applicable to the company business and strategy and review existing procedures;

- Prepare Quality and/or Regulatory Systems and Tools related documentation and training;

- Participate in Audits/inspections (Internal and of Health Authorities);

- Perform other Corporate key activities, such as delivering Corporate Quality or Regulatory KPI’s, Corporate Quality or Regulatory Training, Quality and/or Regulatory Systems Management (e.g., Documentation Management System), CAPA, Change Control, corporate analytical electronic systems, filings, customer support etc.);

- 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;

- Lead initiatives within group or department, ensuring plan definition and timely execution;

- Make quality and timely decisions within the Quality and/or Regulatory Systems’ tasks under her / his responsibility;

- Gather relevant data to inform the decision makers regarding complex issues;

- 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;

- Execute professional activities in compliance with applicable Quality, Regulatory 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) May qualify as internal GMP auditor.

O que precisas de garantir

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

- Typically requires 3-5 years of relevant experience in operational areas (e.g., Quality Control, Quality Assurance, Manufacturing, R&D, Engineering), preferably within the Pharmaceutical Industry;

- Strong understanding and knowledge of Quality and/or Regulatory requirements, cGMP´s, ICH, CFR, EU, local or any other as applicable guidelines and ISO Standards as applicable with the ability to solve complex problems;

- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down;

- Fluency in English is a requirement;

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

O que te proporcionamos

- Salary compatible with function;