Senior R&D Compliance Officer at ELPEN Pharmaceutical Co. Inc.

, , Greece -

Full Time

Start Date

Immediate

Expiry Date

13 Apr, 26

Salary

0.0

Posted On

13 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GMP, Health And Safety, Quality Assurance, Communication Skills, Organizational Skills, Time Management, Team Spirit, Attention To Detail, Audit Management, Procedure Writing, CAPA Management, Training Implementation, Validation Master Plan, Deviation Management, Change Control, Collaboration

Industry

Pharmaceutical Manufacturing

Description

Job Description 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

Responsibilities

The Sr R&D Compliance Officer will document and monitor the implementation of the Quality Assurance System to ensure product quality. Responsibilities include drafting procedures, managing deviations, and coordinating audits.