Job Description
Job Title:  CSV Supervisor
Job Location (Short):  Cyprus, Limassol
Req ID:  772

Remedica is a leading pharmaceutical company located in Cyprus with pharmaceutical products being distributed in more than 160+ countries worldwide. Originally founded in 1980, it went through various development stages. Today Remedica is specialising in the development, production, and sale of high-quality, safe, and efficacious pharmaceutical products for human use. Our pharmaceutical range consists of a product portfolio of more than 300 generic, branded generic, and over-the-counter (OTC).

Over the last few years, Remedica went through a massive transformational program from a locally recognized reputable company to a global player, respected by its distributors, partners, and clients. The investments into the factories, R&D equipment, new facilities, implementation of best-in-class software, and people development are the baselines for Remedica's success in the future.

 
Job Description: 

 

We are looking for:
 

Highly skilled and experienced CSV specialist to join our dynamic team in the pharmaceutical industry.
You will be responsible for ensuring the integrity, compliance, and validation of computerized systems critical to our operations. Expertise in the validation of SAP ERP Systems is mandatory whereas expertise in validation of eQMS systems will be highly valued and considered.
The successful candidate will have a strong background in GxP compliance, computer system validation (CSV), and lifecycle management of computerized systems.


As a CSV Supervisor you will:

  • Lead and execute validation activities for computerized systems compliance with regulatory requirements and guidances (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5).

  • Develop and maintain validation documentation, including Validation Plans, Risk Assessments, Test Scripts (IQ/OQ/PQ), and Summary Reports. Assist in creating URS, Functional Specifications, Design Specifications, Configuration Specifications documents

  • Ensure existing and proposed systems are validated and maintained in a state of control throughout their lifecycle. Review software change requests and test scripts. Handling of defects and deviations to ensure validated state of systems

  • Ensure all computerized systems comply with GxP, data integrity, and regulatory requirements.

  • Support internal and external audits, including regulatory inspections, by providing necessary documentation and evidence of compliance.

  • Conduct periodic reviews and risk assessments of validated systems.

  • Identify opportunities for process improvements and system enhancements to increase efficiency and compliance.

  • Stay updated on industry trends, regulatory changes, and best practices related to computerized systems and validation.

What you will bring:

  • Bachelor’s degree in a science discipline, or a related field.

  • Minimum of 4-5 years of experience in computerized system validation and lifecycle management within the pharmaceutical or life sciences industry.

  • Proven expertise in validating SAP ERP cloud-based systems

  • Strong knowledge of GxP regulations, FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.

  • Excellent understanding of system validation methodologies and tools.

  • Experience in a pharmaceutical/ life science industry or regulated software development company

  • Strong computer literacy skills

  • Strong analytical and problem-solving skills.

  • Effective communication and interpersonal skills, with the ability to work collaboratively across teams.

  • Proficiency in project management and the ability to manage multiple tasks simultaneously.

  • Excellent command of the English language, both written and oral

  • Proven expertise in validating Veeva vaults will be considered a plus

  • Experience with other quality management systems (QMS) and enterprise resource planning (ERP) systems.

  • Knowledge of cloud-based systems and data integrity principles.

 

Why Join Remedica? At Remedica, we offer a competitive compensation package, including 14 salaries, a provident fund, and a range of additional benefits to support your personal and professional growth. Join our team and be part of a company that values innovation, teamwork, and continuous improvement.
Apply now