CSV Analyst (Rodopi)

Job description

For almost six decades, Pharmathen has remained committed to its vision of improving patients’ lives through innovation and expanding access to complex pharmaceutical therapies.

Today, Pharmathen's capabilities extend across a broad range of specialized dosage forms, including sustained-release products, long-acting injectables, and oral solid dosage forms, while its portfolio includes more than 100 commercial products available internationally through a strong network of partners.

These activities are supported by a robust Research & Development and Manufacturing ecosystem, with three facilities in Greece.

The driving force behind Pharmathen is its people. With more than 1,600 employees representing 27 nationalities, the company fosters a multicultural workplace where women account for 53% of the workforce and 40% of the Senior Leadership Team.

Grounded in its shared values of integrity, quality, innovation, leadership and performance, and guided by strong business ethics and a commitment to its vision, Pharmathen remains dedicated to its founding mission: improving patients' lives.

Pharmathen offers a great opportunity for career development and is seeking to recruit a CSV Analyst to join our Business Applications & Systems Validation team at our Sapes premises .

The CSV Analyst ensures that computer systems and their use comply with the regulatory requirements (including guidelines and current practice).

More particularly:

What you’ll do: - Participate in generation & execution of various GMP related documents and protocols, including several of the following: URS, FS/ DS, IQ, OQ & PQ - Participate in the creation, revision and implementation of IT related policies or procedures - Assist in the audit, review, development and implementation of computerized systems to ensure they meet required standards of quality and compliance - Assist with queries regarding computer systems operation, development and validation during regulatory and due diligence inspections - Collaborate with other departments to monitor compliance with standards/ regulations which dictate the operation of the company’s IT systems - Communicate with external parties (customers, suppliers) to ensure appropriate level of support - Manage and support the core project team/ users on a day-to- day basis.

Requirements

Minimum Qualifications: - BSc n Electrical Engineering, Computer Science or relevant field

Minimum Experience: - Minimum 2 years’ experience in a similar role - Basic knowledge of Computerized Systems Validation—Legislation

Job-Specific Skills: - Preparation of Validation/ Verification Protocols (URS, FS, DS documents) - Preparation of automated/ manual testing scripts (IQ/ OQ/ PQ Documents) - Participation in SAT (Site Acceptance Test)/ UAT (User Acceptance Test) Activities - Good Documentation Practices - Risk Management Methodology for Validation - IT- QA Audits for leveraging software supplier - Deviation Investigation - Change Control Management

Benefits

What you will 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/ scientific 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.