CSV Specialist

COMPUTERIZED SYSTEM VALIDATION (CSV) SPECIALIST JD

Location: Onsite/Offshore (Relocation assistance available for candidates willing to move to Germany)

Company Overview:

We at Entiovi Technologies , provide digital transformation using new-age intelligent technologies for more than 7 years . We have clients located primarily in the US and Europe thatare served by our dedicated teams. This job is part of our expansion in India.

Job Description:

We are seeking highly motivated individuals to join our team as Computer System Validation (CSV) Specialist. In this role, you will be responsible for ensuring that our computerized systems meet regulatory requirements and internal quality standards. Your primary responsibilities will include:

• Developing and establishing appropriate Computer System Validation and Data Integrity standards in alignment with internal and external regulations, in collaboration with the QA Qualification and Validation team
• Ensuring that internal regulations are up-to-date and compliant with current regulatory requirements for CSV and Data Integrity (DI)
• Coordinating CSV and DI activities for projects involving new and existing computerized systems, including the authoring of necessary documentation
• Providing support and consultation during the procurement and implementation phases of new computerized systems, including supplier qualification
• Advising and supporting the IT department in the commissioning and maintenance of qualified IT systems, including IT infrastructure
• Conducting internal CSV and DI trainings to ensure awareness and compliance across departments
• Acting as a Subject Matter Expert (SME) for CSV during internal and external audits, as well as agency inspections
• Assisting teams in the creation of user requirement specifications for computerized systems

Qualifications:

• Degree in IT/CS or other engineering or chemistry or pharmaceuticals or life sciences
• Experience in the pharmaceutical industry, particularly with LIMS, ELN, DMS, ERP, CDS, etc.
• Interest in technical systems and understanding of process technology involving computer-controlled equipment and analysis systems
• Extensive knowledge and experience in the domain of Computer System Validation (CSV) and/or Data Integrity (DI)
• Strong understanding of GxP (GLP, GMP, GCP, etc.)
• Proven experience as an SME in audits and regulatory inspections
• Experience with cloud-based GMP systems is a plus
• Speaking fluency in German will definitely be a plus

Key Attributes:

• Detail-oriented with strong analytical skills
• Excellent communication and interpersonal skills
• Ability to work independently and collaboratively in a team environment
• Strong organizational and time-management abilities
• Willingness to learn and adapt in a dynamic work environment

Why Join Us:

• Competitive salary at par with market standards
• Opportunity for continuous growth
• Working with highly skilled team who prides in excellence of their solutions
• Opportunity to work on cutting edge technologies

If you are passionate about ensuring compliance and quality in computerized systems, and you meet the qualifications outlined above, we welcome you to apply for this exciting opportunity. Please submit your resume and cover letter detailing your relevant experience and why you are interested in this position to

PREFERENCE WILL BE GIVEN TO IMMEDIATE JOINERS