Hovione Overview
Hovione is an independent family-owned international group of companies. As a Contract Development and Manufacturing Company, we help Pharmaceutical Customers bring new and off-patent drugs to market.
We are a team of over 1,950 people from 36 different nationalities, located across Asia, Europe, and North America. Our innovative technological and productive capabilities have earned us a top spot in the world market.
At Hovione, we strive for excellence in everything we do: for our clients, partners, and patients. That's why we're In it for life.
About the Role
This role involves defining and implementing quality control techniques to verify the quality of raw materials, intermediate, and end products according to regulatory requirements.
You will be responsible for managing and controlling all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
Key Responsibilities:
* Define and implement quality control techniques
* Manage and control QC activities
* Ensure effective information flow between QC team and stakeholders
* Participate in meetings with internal and external customers
* Provide collaborative support in analytical problem resolution
* Propose changes to QC procedures or analytical methods
* Maintain product specifications according to appropriate standards
* Issue and follow-up change controls
* Assure good functioning equipment and maintenance planning
* Accurately use and maintain laboratory information systems
* Prepare protocols, reports, and QC documentation
* Request quotations and propose instrument acquisition
* Manage reserve/retention samples
* Initiate events and deviations in the CAPA system
* Lead and participate in root-cause investigations
* Determine root cause of events and deviations
* Complete OOS/OOT laboratory deviation investigations
* Monitor progress and follow-up corrective actions
* Assess impact of changes to facilities/systems/equipment/stability
* Perform periodic checks of laboratory documentation
* Be an advocate for safe operating and high-quality performance
* Prepare and participate in internal/external audits
* Ensure tasks are planned and delivered on time, safely, efficiently, reliably, and cost-effectively
Requirements
* University qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or similar field
* Typically requires 3-5 years of relevant experience in a QC laboratory environment
* Training and experience of GMP and ICH standards
* Experience of HSE rules and regulations
* Strong understanding and knowledge 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
* Computer literacy with good working knowledge of the MS Office package
About Us
We are a proud Equal Opportunity Employer and value diversity and inclusion. 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.