The Sr R&D Compliance Officer will report to the R&D Compliance Manager and will be responsible for documenting and monitoring the implementation of the Quality Assurance System, with the aim of ensuring product quality and achieving the objectives of the Department.
The role requires strong coordination and communication skills with both internal departments and external partners/suppliers, ensuring compliance with applicable regulatory requirements (GMP, ISO, etc.).

The position includes responsibilities covering the entire R&D Department (Analytical/Formulation, CMC), as it will support both manufacturing sites (Pikermi & Keratea).

Responsibilities:

·     Drafting, reviewing, and revising procedures and SOPs related to the Department

·     Participation in the implementation of new systems and programs (or projects) related to product quality

·     Management of deviations and change controls

·     Preparation, issuance, and monitoring of the implementation/execution of corrective and/or preventive action plans (CAPAs)

·     Coordination and documentation of Cleaning Validation studies

·     Implementation of the personnel training process

·     Monitoring the implementation of the Validation Master Plan

·     Audit preparation and conducting internal audits

·     Submission of proposals to improve the Department’s operations

·     Collaboration with involved departments for the implementation of the Quality Management System (QMS) procedures

·     Responsibility for compliance with Health and Safety rules, in accordance with applicable legislation

Technical Skills:

·     Knowledge of  GMP's, Health and Safety requirements

·     Ability to write and review Procedures / Policies / Files / Instructions / Certificates / Protocols

·     Languages

·     Software Tools (Microsoft, QMS)

·     Audit Management Skills

Required Qualifications/:

·     University Degree in Chemistry, Pharmacy, or in a relevant scientific discipline

·     At least 2 years of experience in a similar role

·     Fluent in English and Greek

·     Advanced computer skills (PC literacy)

·     Strong organizational and time-management skills

·     Team spirit and effective communication skills

·     Strong sense of responsibility with excellent attention to detail

·     FDA/ Anvisa experience will be considered as an asset