QC Associate

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.

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

Guide less experienced colleagues in the undertaking on all assigning project tasks

Propose new methodologies taking into consideration project demands and requirements

Execute project specific analytical tasks and act as a stakeholder liaison

Provide an example of professionalism and lead the induction and training of new colleagues within the area

Ensure that all 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 personal work and proactively supporting less experienced colleagues

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, establishing relationships and representing the team 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 a leading 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

Proactively assist with audits / investigations as required, following the instruction of QC Management.

Collaborate with management in developing, generation and proactive reporting of KPIs for the team.

Maintain advanced analytical chemistry expertise, sharing knowledge of new technologies and methodologies within the area

Lead relevant training delivery to other areas in accordance and support development of training plans by recommending training needs

Lead the induction and training of new colleagues

Drive high standards in the QC Laboratories

Use, and support others on the use of, 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

Master Quality control processes and tools

Manage complex projects/ analysis with significant impact on business

Make quality and timely decisions based on multiple sources of data

Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals

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.

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

We are looking to recruit a Candidate::

Master's degree 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 pharmaceutical QC laboratory environment (mandatory)

Strong hands-on experience in Analytical Chemistry, Development and Validation of analytical methods and QC procedures (mandatory)

Advanced training and experience of GMP and ICH guidelines standards (mandatory)

Good working knowledge on HPLC and GC, and familiarity with Empower Software (mandatory)

Advanced knowledge of GMP practices, analytical theory and techniques with the ability to solve complex problems.

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.

Strong documentation skills and attention to detail

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.

#J-18808-Ljbffr Gestão e operações