Job Description

Lavipharm is seeking a Specialist Product Release / QP based in Athens, reporting to the Manager Quality Operations. The successful candidate will be responsible for the final review and certification of batches for release to market, acting in accordance with Directive 2001/83/EC and the obligations of a Qualified Person under EU GMP.

Key Responsibilities:

• Personal, non-delegable accountability for batch certification — you will be the signing QP under Directive 2001/83/EC and Annex 16, exercising independent professional judgement on every release decision, not executing a team-delegated task.
• Final independent quality verification before commercial release — the role sits between QA Operations team activity and the market, providing the critical assurance layer that every batch meets its MA dossier, GMP requirements, and applicable national obligations.
• Full Annex 16 QP responsibility scope — covering all 21 certification obligations including GMP compliance verification, analytical testing confirmation, deviation and change control assessment, supply chain security, labelling, and documentation completeness.
• Multi-market release portfolio — certification covers products distributed across EU, Taiwan, Canada, and other export markets, each with jurisdiction-specific requirements to be verified prior to release.
• Controlled substance certification expertise required —heightened regulatory scrutiny and narcotic control compliance verification are integral parts of the certification process.
• Risk-based quality decision-making — the role requires cumulative risk assessment across deviations, OOS/OOT results, CAPA status, complaints, and process performance history before every certification; right-first-time documentation quality is a key metric.
• Formal QP qualification is mandatory — candidates must hold Qualified Person designation per Directive 2001/83/EC and national competent authority requirements, with a minimum of 5 years GMP QA experience including direct batch certification exposure.
• Dual MAH/CMO operating environment — the role covers both Lavipharm's own licensed products as MAH and CMO-manufactured batches, requiring QTA compliance verification and equivalent GMP standard assessment for each certification scenario.
• Direct interface with regulatory authorities and MAH partners — the QP will act as technical reference during regulatory inspections, co-sign recall documentation where QP attestation is required, and support NCA correspondence related to batch release.

Requirements

• University degree in Pharmacy, Chemistry, Chemical Engineering, or a related Life Science discipline meeting the eligibility requirements of Directive 2001/83/EC for Qualified Person designation.
• Formal Qualified Person (QP) qualification/registration, or eligibility to be named as QP, in accordance with national competent authority requirements.
• Minimum 5 years of GMP Quality Assurance experience in a pharmaceutical manufacturing environment, with direct exposure to batch certification activities.
• Practical experience applying Annex 16 batch certification principles.
• Excellent Knowledge of the English language
• eQMS / eDMS experienced user would be an asset