Senior Qc Technical Specialist

2 meses atrás

Loures, Portugal Hovione Tempo inteiro

Join a Market Leader:
Hovione 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 stakeholders and uses this information to plan general activities of the department
- Participate in meetings with internal and external customers as representative of analytical area, providing information on the status of activities and technical expertise to help solving any challenges identified.
- Define analytical strategies to support the resolution of analytical problems relating to assigned projects / initiatives and provide collaborative and timely support to all areas
- Propose and prepare 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
- Support other colleagues in creating a proper plan for the maintenance, internal calibration plans, reference standards and internal qualifications of all laboratory instruments
- Accurately use and maintain all laboratory information systems, proposing and participating in the implementation of lab systems improvements
- Prepare complex protocols, reports, QC documentation and review records to ensure compliance with cGMP and HSEE standards
- Review proposals for the acquisition of instruments, materials and reagents to guarantee the stock control and operation of the laboratories, making the necessary adjustments
- 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
- Assess all data and information associated with the investigation or deviation to determine the appropriate next steps in accordance with the approved workflow
- Review and support the completion/ close out of complex OOS/OOT laboratory deviation investigations and QC incident
- Perform a holistic review of deviations/events/change controls generated in QC and ensure CAPAs are in place prevent recurrence.
- Perform trending of the direct causes/ root causes of events and deviations, and issue periodic reports to QC management
- Assess the impact of complex changes to facilities/systems/equipment/stability and processing of change control documents
- 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 and ensuring the implementation of optimizations or improvements to internal procedures
- Lead audit preparation activities for the QC department, so the area is permanently inspection ready and participate in internal/external audits as required, performing periodic internal gap analyses as needed and required
- Review the compilation of audit responses for QC
- Participate in other departments’ internal audits and in suppliers’ qualification audits as auditor, as long as he/she has training for the function.
- Prepare and deliver general quality related training programs, including (but not limited to) GMP, deviation writing, description writing, investigations, RCA and change controls
- Support the generation / reporting of KPIs for the team and verify the accomplishment of the team KPIs
- Master Quality Control processes and tools under own responsibility (e.g. instrumentation, deviation, stab

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