QC Technical Specialist - Temporary

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.

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.

• 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.
• Prepare and implement changes to QC procedures and analytical methods, ensuring proper approvals.
• Issue, track, and follow up on change controls and CAPA-related events within required timelines.
• Ensure proper functioning, maintenance, calibration, and qualification of lab instruments and reference standards.
• Maintain and improve lab information systems; prepare and review QC documentation, protocols, and reports in compliance with cGMP and HSEE.
• Request quotations and manage stock control for instruments, materials, and reagents to ensure lab operations.
• Lead/conduct and participate in root-cause investigations, document findings, and support closure of OOS/OOT incidents and QC deviations.
• Apply investigation tools in analytical investigations (internal or cross functional investigations).
• Define CAPAS aligned with the root-cause determination.
• Support internal and external audits and assist in compiling audit responses related to QC. Perform tasks safely and efficiently, monitor risks, and ensure adherence to HSE and GMP standards.
• Apply and expand QC knowledge in instrumentation, stability, and deviation handling under senior guidance.
• Deliver assigned tasks reliably, on time, and cost-effectively, while complying with company policies and procedures.

• University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar Chemistry, Biochemistry or Health Sciences field (mandatory)
• Typically requires 3-5 years of relevant experience in a QC laboratory environment, preferably under pharmaceutical cGMP (desired)
• Training and experience of GMP and ICH standards (mandatory)
• Experience of HSE rules and regulations (mandatory)
• Experience of investigational analysis (desired)
• 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 is a requirement
• Computer literate with good working knowledge of the MS Office package

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.

Notice to Agencies and Search Firms Representatives

Hovione does not accept unsolicited resumes from agencies or search firms for this job posting. Any resumes submitted to Hovione by a third-party agency or search firm without a valid written and signed search agreement will become the sole property of Hovione. No fees will be paid if a candidate is hired for this position as a result of an unsolicited referral.