Senior Qc Technical Specialist

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 for:

Defining and implementing 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.
Managing and controlling all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
Ensuring the effective and proactive flow of information and requests between the QC team and the internal and external stakeholders and using this information to plan general activities of the department.
Participating in meetings with internal and external customers as representative of analytical area, providing information on the status of activities and technical expertise to help solve any challenges identified.
Defining analytical strategies to support the resolution of analytical problems relating to assigned projects/initiatives and providing collaborative and timely support to all areas.
Proposing and preparing procedures or analytical methods for onwards approval and implementation.
Assuring product specifications are maintained in accordance with appropriate standards and proposing revisions as required.
Issuing and following-up change controls.
Supporting other colleagues in creating a proper plan for the maintenance, internal calibration plans, reference standards and internal qualifications of all laboratory instruments.
Accurately using and maintaining all laboratory information systems, proposing and participating in the implementation of lab systems improvements.
Preparing complex protocols, reports, QC documentation and reviewing records to ensure compliance with cGMP and HSEE standards.
Reviewing proposals for the acquisition of instruments, materials and reagents to guarantee the stock control and operation of the laboratories, making the necessary adjustments.
Managing reserve/retention samples.
Initiating events and deviations in the CAPA system in accordance with the required timeframes and in partnership with appropriate colleagues, completing relevant section/s of the event or deviation.
Leading and participating in root-cause investigations, guiding colleagues (as required) in the necessary investigative testing.
Assessing all data and information associated with the investigation or deviation to determine the appropriate next steps in accordance with the approved workflow.
Reviewing and supporting the completion/close out of complex OOS/OOT laboratory deviation investigations and QC incidents.
Performing a holistic review of deviations/events/change controls generated in QC and ensuring CAPAs are in place to prevent recurrence.
Performing trending of the direct causes/root causes of events and deviations, and issuing periodic reports to QC management.
Assessing the impact of complex changes to facilities/systems/equipment/stability and processing of change control documents.
Being 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.
Leading audit preparation activities for the QC department, so the area is permanently inspection ready and participating in internal/external audits as required, performing periodic internal gap analyses as needed and required.
Reviewing the compilation of audit responses for QC.
Participating in other departments' internal audits and in suppliers' qualification audits as auditor, as long as he/she has training for the function.
Preparing and delivering general quality related training programs, including (but not limited to) GMP, deviation writing, description writing, investigations, RCA and change controls.
Supporting the generation/reporting of KPIs for the team and verifying the accomplishment of the team KPIs.
Mastering Quality Control processes and tools under own responsibility (e.g. instrumentation, deviation, stability).
Managing complex projects/analysis with significant impact on business.
Making quality and timely decisions based on multiple sources of data.
Managing risk and uncertainty; anticipating and escalating roadblocks in order to prevent deviations to the goals.
Executing professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promoting the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).
Undertaking any additional tasks commensurate with the role as and when required.
Carrying out assigned tasks and duties in a safe manner, in accordance with instructions, and complying with environmental, health & safety rules/procedures, regulations and codes of practice.

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 5-8 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 (mandatory).
Advanced knowledge of GMP and ICH practices, analytical theory, and techniques with the ability to solve complex problems.
Strong knowledge of EU/US quality related pharmaceutical regulations.
Proven experience 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.
Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.

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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