Lavipharm

Operations

• People management accountability — full line management of the QA Operations team including objective setting, performance reviews, development plans, capacity management, and GMP training oversight.
• Lead a dedicated Quality Operations team responsible for day-to-day quality operations interfaces, within a dynamic dual MAH/CMO pharmaceutical environment. Act as the primary quality decision-maker for operational disruptions while applying risk-based decisions to safeguard product quality and patient safety
• QP & Accountable for batch release and disposition — oversight batch release team, review of batch records, in-process controls, and yield evaluations; holding final approval authority on disposition recommendations prior to QP certification.
• Own Product related investigations related to deviations, OOS/OOT, and complaints management system end-to-end — from incident classification to investigation through CAPA plan design, assignment, closure, and effectiveness verification.
• Lead recall and market withdrawal operations for both MAH-initiated and CMO-received scenarios, including regulatory authority notification, batch traceability, mock recall programs, and QTA compliance.
• Product & Process change control management—oversight change controls impact assessments and risk management, approving outputs, representing Quality in cross-functional change boards, and engaging Regulatory Affairs where MA impact is identified, monitoring of Change control completion, verification and effectives checks
• Oversee Product Quality Reviews and product risk assessments — ensuring PQRs are developed and critically evaluated in due time and in line with EudraLex Volume 4. Oversee the Quality operation team deliverables in relation to product Lifecyle management Risk Assessments ( eg. elemental impurities, Nitrosamines)

Manager, Quality Operations

Product Specialist

• Personal, non-delegable accountability for batch certification
• Final independent quality verification before commercial release
• Full Annex 16 QP responsibility scope
• Multi-market release portfolio
• Controlled substance certification expertise required
• Risk-based quality decision-making
• Formal QP qualification is mandatory
• Dual MAH/CMO operating environment
• Direct interface with regulatory authorities and MAH partners

Product Release Specialist

Auditor

• Perform financial, operational, compliance, and risk-based audits in accordance with the annual audit plan.
• Evaluate governance, risk management, and internal control systems, recommending improvements where needed.
• Identify risks, control gaps, and process inefficiencies, and support the implementation of corrective actions.
• Prepare audit reports and communicate findings to management and relevant governance bodies.
• Support fraud investigations, regulatory compliance reviews, and ad-hoc audit assignments.
• Utilize data analytics and technology to enhance audit quality and efficiency.
• Maintain up-to-date knowledge of regulatory requirements, audit standards, and industry best practices.

Senior Internal Auditor

Compliance

• Evaluate the technical documentation and prepare the technical dossier for different categories of products [i.e. CMC writing and Compilation of Common Technical Document (CTD) Module 3 and Module 2.3 (Quality Overall Summary), required for registration of new pharmaceutical products or variation & renewal applications for existing products], under minimum supervision
• Maintain current knowledge of relevant regulations, including proposed and final rules
• Implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained
• Ensure compliance with the company’s policies and procedures
• Ensure the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of department activities
• Work with specialist computer software and resources of the pharmaceutical products/raw material
• Communicate with all departments to ensure and provides properly and effectively any CMC regulatory support as required.
• Co-ordinate with R&D, Quality and Operations teams to ensure compliance to the relevant guidelines

Manager, Quality Operations

Product Release Specialist

Senior Internal Auditor

Senior Specialist, Regulatory Affairs, CMC