Zenovative Technology Looking for IT Gxp systems Generalist at Bengaluru, Karnataka Full Time

Experience: 2-6 years
Job Type: Full-time

Essential Duties and Responsibilities

• Strong understanding of the current pharmaceutical industry and computerized system regulations, including CFR Part 11.
• Knowledge in EQMS like Trackwise; LIMS; DMS ; LMS/TMS; Clinical Systems; Serialization etc
• Strong knowledge of appropriate Quality Systems and current Good Manufacturing Practice requirements (FDA, EU, ICH) with the ability to assess compliance risks.
• Experience in providing oversight in implementing and maintaining GxP computer systems in a validated state.
• Strong working knowledge in validation methodology and software development life cycle (SDLC) principles.
• Strong organizational skills, planning skills and must work effectively within teams.
• Demonstrates good coping skills and analytical problem solving skills.
• Ability to resolve conflicts and disputes on regulatory compliance issues.
• Ability to perform limited travel both domestically and internationally.
• Collaborate with System Owner to develop Design Qualifications, Functional Requirements, User Requirements, unit test scripts, UAT scripts, validation plans, validation summary report, traceability matrix, IQ/OQ/PQ.
• May support, coordinate, and interface with regulatory agencies as required in support of regulatory agency inspections.
• Perform Validation/Part 11 Assessments for new and existing computer systems.
• Perform scheduled reviews of existing GxP Systems and define remediation plans for non-conformances.
• Maintain GxP System Log and update as necessary.
• Identify and implement opportunities for continuous improvement related to validation or other compliance practices/issues based on internal compliance issues, industry best practices as well as latest regulatory guidance’s and regulatory updates.
• Support and maintain Quality programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP) expectations and established agency requirements/guidelines.

Education Requirements and Qualifications

• Bachelor’s degree and a minimum of 3-6 years’ experience dealing with GxP computer systems in the pharmaceutical or similar regulated industry.

Job Types: Full-time, Regular / Permanent

Salary: ₹300,000.00 – ₹800,000.00 per year

Schedule:

Ability to commute/relocate:

• Whitefield, Bengaluru – 560066, Karnataka: Reliably commute or planning to relocate before starting work (Required)

Education:

Experience:

• total work: 2 years (Preferred)
• Trackwise Digital/Salesforce: 2 years (Required)