80 AceNet Jobs
·
5-15 years
Pune, Gurgaon / Gurugram, Bangalore / Bengaluru
1 vacancy
Computer Systems Validation S
AceNet
posted 8hr ago
Key skills for the job
About Us:
AceNet Consulting is a fast-growing global business and technology consulting firm specializing in business strategy, digital transformation, technology consulting, product development, start-up advisory and fund-raising services to our global clients across banking & financial services, healthcare, supply chain & logistics, consumer retail, manufacturing, eGovernance and other industry sectors.
We are looking for hungry, highly skilled and motivated individuals to join our dynamic team. If you re passionate about technology and thrive in a fast-paced environment, we want to hear from you.
Job Summary:
We are seeking a highly skilled and experienced Validation Specialist to lead and execute the Computer Systems Validation (CSV) activities for IT systems used in pharmaceutical manufacturing environments.
Key Responsibilities
1.Validation Documentation:
*Author comprehensive Validation Plans, Test Plans, and Requirements Specifications.
*Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) test scripts.
*Prepare and review detailed Test Execution, Test Reports, and Validation Reports.
2.System Validation and Deployment:
*Oversee global and local deployments of manufacturing IT systems, ensuring compliance with regulatory guidelines (e.g., FDA, EMA, GxP).
*Support system validation for new implementations, upgrades, and system modifications.
3.Compliance Management:
*Ensure all IT systems comply with applicable regulations, standards, and internal policies.
*Drive effective change management and handle deviation management processes.
4.Testing and Quality Assurance:
*Collaborate with cross-functional teams to execute rigorous system testing and validation activities.
*Ensure traceability between requirements, test cases, and executed results.
5.Agile Practices (Preferred):
*Contribute to Agile methodologies and practices, supporting iterative system development and validation.
6.Stakeholder Engagement:
*Work closely with project teams, Quality Assurance, IT, and Manufacturing teams to ensure smooth project execution.
*Communicate effectively to report progress, issues, and compliance metrics.
Role Requirements and Qualifications:
*Minimum 5 years of experience in CSV within the pharmaceutical industry.
*Proficient in authoring validation deliverables, including Validation Plans, Test Scripts (IQ, OQ, PQ), and Reports.
*Experienced with global and local deployments of manufacturing systems.
*Experience working in Agile environments or familiarity with Agile methodologies.
Why Join Us:
Opportunities to work on transformative projects, cutting-edge technology and innovative solutions with leading global firms across industry sectors.
Continuous investment in employee growth and professional development with a strong focus on up & re-skilling.
Competitive compensation & benefits, ESOPs and international assignments.
Supportive environment with healthy work-life balance and a focus on employee well-being.
Open culture that values diverse perspectives, encourages transparent communication and rewards contributions.
How to Apply:
If you are interested in joining our team and meet the qualifications listed above, please submit your resume and a cover letter detailing your experience and why you are the ideal candidate for this position.
Employment Type: Full Time, Permanent
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