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Qc Technical Specialist
4 meses atrás
Join a Market LeaderHovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.
Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.
Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.
You will be responsible to: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.
We are looking to recruit a Candidate:- 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
Hovione is a proud Equal Opportunity Employer Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.
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