CSV Analyst

Pharmathen is one of the leading complex drug delivery and formulation developers and is among the top 50 pharmaceutical research companies in Europe. Driven by innovation, the company specializes in one of the most modern and technologically innovative sectors, developing Long Acting Injectables (LAI), Sustained Release formulations and Preservative Free Ophthalmics.

Pharmathen’s portfolio consists of over 100 products, produced at its facility in Sapes, Rodopi, approved by the US Food and Drug Administration (FDA), and at its modernized production unit in Pallini, Attica.

Pharmathen is one of the largest private investors in research and development in Greece, with steady investments of €35 million annually in the R&D sector and employs over 1,350 people from over 24 different nationalities. The company's enduring success is attributed to the passion for creativity, the ethics, and dedication of its people, who share the company's vision of making a difference in people’s lives.

Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to attract a CSV Analyst to join our Business Applications & Systems Validation team at Pharmathen’s Marousi premises.

As a CSV Analyst you will be responsible to ensures that computer systems and their use comply with the regulatory requirements (including guidelines and current practice).

More particularly:

What you’ll do:

• Participate at the generation & execution of various GMP related documents and protocols, including URS, FS/DS, IQ, OQ & PQ
• Participate at the creation, revision and implementation of IT related policies or procedures.
• Assist in the audit, review, development and implementation of computerized systems to assure they meet required standards of quality and compliance
• Assist in queries regarding computer systems operation, development and validation during regulatory and due diligence inspections
• Collaborate with other departments to monitor compliance to standards/regulations that dictate the operation of the company’s IT systems
• Communicate with external parties (customers, suppliers) to ensure an appropriate level of support.
• Manage and support the core project team/users on a day-to-day basis
• Configure, and control operating systems, software applications, for ensuring the data integrity of GxP critical data.
• Assist in managing user accounts, permissions, and access rights across various systems and applications

Requirements

The ideal candidate should have:

• BSc in Electrical Engineering, Computer Science or relevant field
• Minimum of 4 years experience in a similar role
• Basic knowledge of Computerized Systems Validation – Legislation

Job-Specific Skills:

• Proficient with MS word and other computer skills
• In depth knowledge of preparation of Validation/Verification Protocols (URS, FS, DS documents)
• In depth knowledge of preparation-execution of automated/manual testing scripts (IQ/OQ/PQ Documents)
• Participation on SAT (Site Acceptance Test)/ UAT (User Acceptance Test) Activities
• Good Documentation Practices
• Strong understanding of Risk Management Methodology for Validation
• IT-QA Audits for leveraging of software supplier
• Experience in Deviation Investigation
• Change Control Management
• Excellent communication in English language (writing & speaking)

Benefits

What you'll gain:

• Involvement in a high-caliber, team-oriented and dynamic atmosphere
• Exposure to challenging business issues and practices
• Great opportunity to leverage and develop your business knowledge and skills

Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career!

Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.