Associate Analytical Data Reviewer

Há 1 mês

Lisboa, 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:

- Responsible for data from chemical analyses such as HPLC, GC, DSC, XRPD, PSD
- Rigorously, accurately, efficiently and professionally manage, execute and support all assigned projects in accordance with applicable GMP, quality operational standards / procedures and legal regulations, escalating as appropriate
- Propose new methodologies taking into consideration project demands and requirements
- Execute project specific analytical tasks and act as a stakeholder liaison
- Ensure that all assigned analytical tasks, including (but not limited to) method development, method creation, method transfer, method validation, protocol preparation and report preparation, in any analytical project is well managed and delivered on time, safely, efficiently, reliably and in a cost-effective manner by performing and planning
- Solve analytical problems relating to assigned projects by providing collaborative and timely support to all areas and departments, initiating the problem-solving escalation process when unable to solve occurrences within the established period
- Ensure the effective and proactive flow of information between the Analytical team and the internal and external (if applicable) stakeholders, representing the team (with support from senior colleagues) as appropriate
- Reviews work generated by the team as required ensuring all procedures are followed
- Creation, investigation and evaluation of CAPAS, incidents and deviations
- Perform equipment maintenance, internal calibrations and internal qualifications on designated laboratory instruments
- Accurately use and maintain all laboratory information systems
- To maintain good hygiene and housekeeping within the laboratory
- To maintain all laboratory records, project and general logbooks and notebooks to an acceptable GLP standard and in accordance with Hovione internal procedures
- Fulfil and promote all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities
- Be an advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks, discrepancies, deviations or non-conformance in accordance with Hovione internal procedures, suggesting optimizations or improvements
- Assist with audits / investigations as required, following the instruction of QC Management
- Support the reporting of KPIs for the team, if required - Develop and accumulate strong analytical chemistry expertise
- Maintain high standards in the QC Laboratories
- Use analytical techniques and instrumentation, such as gas and high-performance liquid chromatography (HPLC) amongst others
- Interpretation of data and analysis to ensure meeting strict guidelines on documentation and recording data
- Work collaboratively in cross-functional teams and understand each departments function and role in delivery of tests and products
- Perform to ensure all assigned tasks are delivered on time, safely, efficiently, reliably and in a cost-effective manner
- 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).
- 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.
- University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar Chemistry, Biochemistry or Health Sciences field (mandatory)
- Requires educational / training experience in a QC laboratory environment
- Hands-on experience in Analytical Chemistry and QC procedures (desirable)
- Training and experience of GMP and ICH guidelines standards (desirable)
- Knowledge on HPLC and GC, and familiarity with Empower Software (

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