Quality Control Technical Specialist - Loures - Sete Casas - Clan - Full-time

Detalhes da oferta

Descrição:

Join a global leader in the pharmaceutical industry as a Quality Control Technical Specialist. If you’re passionate about excellence, precision, and continuous improvement, this is your opportunity to contribute to groundbreaking work that impacts lives worldwide. Take the next step in your career and be part of a team that values quality, innovation, and scientific rigor.

O que terás de fazer

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.

- Ensure the effective and proactive flow of information and requests between the QC team and the internal and external (if applicable) stakeholders

- Participate in meetings with internal and external customers as representative of analytical area, providing information on the status of activities

- Provide collaborative and timely support in the resolution of analytical problems relating to assigned projects / initiatives

- Propose and prepare changes to QC procedures or analytical methods for onwards approval and implementation

- Assure product specifications are maintained in accordance with appropriate standards and propose revisions as required

- Issue and follow-up change controls

- Assure good functioning equipment, planning and managing the maintenance, internal calibration plans, reference standards and internal qualifications of designated laboratory instruments

- Accurately use and maintain all laboratory information systems, participating in the implementation of lab systems improvements as required

- Prepare protocols, reports, QC documentation and review records to ensure compliance with cGMP and HSEE standards

- Request quotations and propose the acquisition of instruments, materials and reagents to guarantee the stock control and operation of the laboratories

- Manage reserve/retention samples

- Initiate events and deviations in the CAPA system in accordance with the required timeframes and in partnership with appropriate colleagues, complete relevant section/s of the event or deviation

- Lead and participate in root-cause investigations, guiding colleagues (as required) in the necessary investigative testing, and ensuring appropriate corrective and preventative actions are determined

- Determine the root cause of events and deviations based upon the data and information obtained through the investigation, ensuring appropriate corrective and preventative actions are determined

- Complete or support the completion/close out of OOS/OOT laboratory deviation investigations and QC incidents

- Monitor progress and follow-up corrective and preventative actions

- Monitor the status of open events and deviations and provide periodic status reports to QC management

- Assess the impact of changes to facilities/systems/equipment/stability and processing of change control documents

- Perform periodic checks of laboratory documentation to ensure compliance with applicable operating procedures and identify and implement updates/improvements to current procedures

- Be an advocate for safe operating and high-quality performance within the area, alerting the management of the area to any potential risks, discrepancies, deviations or non-conformance in accordance with Hovione internal procedures, suggesting optimizations or improvements

- Prepare and participate in internal/external audits as requiredSupport the compilation of audit responses for QC

- 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

- Make quality and timely decisions within the 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 Hovione´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.

O que precisas de garantir

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

- Typically requires 3-5 years of relevant experience in a QC laboratory environment, preferably under pharmaceutical cGMP (desired)

- Training and experience of GMP and ICH standards (mandatory)

- Experience of HSE rules and regulations (mandatory)

- Experience of investigational analysis (desired)

- Strong understanding and knowledge of GMP and ICH practices, analytical theory, and techniques

- Knowledge of EU/US quality related pharmaceutical regulations

- Competence in conducting quality-based investigations and root cause analysis

- 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.

Responsabilidades