Hovione is a leading 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 located across Asia, Europe, and North America.
Working at Hovione means striving for innovation and excellence in everything we do: for our clients, partners, and patients. We aim to make a difference through quality services.
Job Description
* Define and implement quality control techniques to verify the quality of raw materials, intermediate products, and end products according to regulatory requirements.
* Manage and control Quality Control activities in accordance with quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
* Evaluate and communicate analytical data to stakeholders.
* Collaborate with cross-functional teams to resolve analytical issues.
* Develop, document, and implement analytical methods and procedures.
* Maintain accurate product specifications and propose revisions as needed.
* Issue and track change controls.
* Maintain laboratory equipment, plan maintenance, and manage calibration plans.
* Maintain lab information systems and participate in system improvements.
* Prepare protocols, reports, and QC documentation to ensure compliance with cGMP and HSEE standards.
* Source instruments, materials, and reagents to guarantee stock control and lab operation.
* Manage reserve/retention samples.
* Initiate events and deviations in the CAPA system.
* Lead root-cause investigations and guide colleagues in investigative testing.
* Determine corrective and preventative actions.
* Monitor progress and follow-up on corrective actions.
* Monitor open events and provide periodic status reports.
* Evaluate changes to facilities, systems, equipment, or processing.
* Ensure laboratory documentation complies with operating procedures.
* Become an advocate for safe operations and high-quality performance within the area.
* Participate in internal/external audits.
* Deliver tasks safely, efficiently, reliably, and cost-effectively.
* Propose process improvements.
* Make quality decisions based on available data.
* Execute professional activities in compliance with GMP and HSE guidelines.
* Undertake additional tasks commensurate with the role.
Requirements
* University qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or similar field (mandatory).
* Typically requires 3-5 years of relevant experience in a QC laboratory environment, preferably under pharmaceutical cGMP (desired).
* Training and experience in GMP and ICH standards (mandatory).
* Experience with HSE rules and regulations (mandatory).
* Experience with investigational analysis (desired).
* Strong understanding of GMP and ICH practices, analytical theory, and techniques.
* Knowledge of EU/US quality-related pharmaceutical regulations.
* Competence in conducting quality-based investigations and root cause analysis.
* Fluency in English is a requirement.
* Computer literacy with good working knowledge of the MS Office package.