Quality Assurance Specialist

We are seeking a highly skilled Quality Assurance Specialist to join our team. This is an exciting opportunity for a detail-oriented individual who is passionate about ensuring the highest quality standards in pharmaceutical manufacturing.

• Job Summary: As a Quality Assurance Specialist, you will be responsible for verifying 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.
• Main Responsibilities:

Main responsibilities include defining and implementing quality control techniques, managing and controlling all Quality Control activities, rigorously, accurately, efficiently and professionally managing, executing and supporting all assigned projects, proposing new methodologies, executing project specific analytical tasks, acting as a stakeholder liaison, providing an example of professionalism, supporting the induction and training of new colleagues within the area, ensuring that all assigned analytical tasks are well managed and delivered on time, safely, efficiently, reliably and in a cost-effective manner, solving 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, ensuring the effective and proactive flow of information between the Analytical team and the internal and external (if applicable) stakeholders, representing the team as appropriate, reviewing work generated by the team as required ensuring all procedures are followed, creating, investigating and evaluating CAPAs, incidents and deviations, performing equipment maintenance, internal calibrations and internal qualifications on designated laboratory instruments, accurately using and maintaining all laboratory information systems, maintaining good hygiene and housekeeping within the laboratory, maintaining all laboratory records, project and general logbooks and notebooks to an acceptable GLP standard and in accordance with Hovione internal procedures, fulfilling and promoting all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities, being 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, assisting with audits / investigations as required, following the instruction of QC Management, supporting the generation / reporting of KPIs for the team, if required, developing and accumulating strong analytical chemistry expertise, sharing knowledge of new technologies and methodologies within the area, providing relevant training to other areas in accordance with established training plans, participating, as required, in the induction and training of new colleagues, driving high standards in the QC Laboratories, using analytical techniques and instrumentation, such as gas and high-performance liquid chromatography (HPLC) amongst others, interpreting data and analysis to ensure meeting strict guidelines on documentation and recording data, working collaboratively in cross-functional teams and understanding each department's function and role in delivery of tests and products, ensuring all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner, proposing improvements to the area as appropriate and solving problems, making quality and timely decisions within the quality control tasks under her / his responsibility, gathering relevant data to inform the decision makers regarding complex issues, 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, must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.

Key Requirements:

• Master's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar Chemistry, Biochemistry or Health Sciences field.
• Typically requires 3-5 years of relevant experience in a pharmaceutical QC laboratory environment (mandatory).
• Hands-on experience in Analytical Chemistry and QC procedures (mandatory).
• Training and experience of GMP and ICH guidelines standards (mandatory).
• Knowledge on HPLC and GC, and familiarity with Empower Software (desirable).
• Strong understanding and knowledge of GMP practices, analytical theory and techniques.
• Fluency in English is a requirement.
• Computer literate with good working knowledge of the MS Office package.
• Good documentation skills and attention to detail.

About Us:

We are 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.