Senior QC Specialist

at  Hovione

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

Please refer the Job description for details