QA Project Lead

About the Company

With over 85 years of experience, UQUIFA Group is a leading manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediates, serving the pharmaceutical and animal health industries worldwide. Operating under cGMP conditions, our manufacturing site in Spain has been inspected and approved by leading global pharmaceutical companies and regulatory authorities, including the US FDA. Since 2018, Soneas Chemicals Ltd., a Budapest-based company focused on CDMO activities, has been part of the UQUIFA Group, enhancing our capabilities in route scouting, process optimization, and both small- and large-scale manufacturing. Our commitment to innovation, quality, safety, passion, environmental sustainability, and flexibility drives us to deliver excellence to our clients in over 70 countries

Our plant in Sant Celoni is looking to hire a QA Project Lead.

As QA Project Lead under supervision of the QA Manager, will be responsible for ensures that CDMO new product development / transfer activities / operations as well as product release are carried out in accordance with applicable cGMP requirements according to the project phase and company and customer requirements. This person will be our QA partner in new product introduction projects (NPI) CMO - at UQUIFA Sant Celoni.

About the Role

Acts as a quality assurance expert (QA SME) for the CDMO new product development / transfer projects to which he / she is assigned. As QA SME on projects, interacts directly with internal and external customers in change control, documentation review and approval, deviation investigation, OOS, incidents and CAPAs (Corrective Action and Preventative Action), and contributes to decision making on quality issues related to cGMP compliance.

Responsibilities

• Interacts with internal and external customers as part of the CMO new product development / transfer project team acting as QA SME.
• Participation in regular meetings (internal and customer) of assigned projects.
• Management and follow-up of QA activities in CMO new product development / transfer projects acting as QA SME.
• Coordination and review of TQA for new CMO products - project.
• Evaluation of change controls on projects. Communication of changes to customers according to Technical Quality Agreement (TQA). Monitoring the implementation of changes.
• Review and approval of product specific documentation : MP / INT / PF Specifications, MP / INT / IPC / PF Methods of Analysis, INT / PF Master Batch Records, INT / PF Stability Protocols, Laboratory Notebooks.
• Follow-up of the evaluation of new suppliers for CMO projects.
• Review and approval of Analytical Methods Transfer Plans, Transfer / Verification / Validation Protocols, Transfer / Verification / Validation Reports.
• Review documentation / findings validation manufacturing process.
• Review Batch record, Lab Record and Release of pre-validation batches and 1st validation campaign according to current SOP.CoA QA signature.
• Support assigned project specific Deviation, OOS and CAPA processes; review and approve investigation reports, including root cause analysis, and ensure corrective and preventive actions address root cause to prevent recurrence. Communication of events to the customer as per TQA agreement.
• Monitoring implementation of CAPAs assigned projects.

Qualifications

Pay range and compensation package