Responsibilities : Execute requirements gathering, elicitation, and development to capture and document business needs. Collaborate with developers and subject matter experts to establish the technical vision and analyse trade-offs between usability and performance needs Verify that the implemented changes are mapped to the user and functional requirements. Compose, edit, and produce documentation for existing and new developed applications/features. Implement changes into the product using Java, Python and SQL. Design high volume web services with complex business logic using RESTful and SOAP APIs to establish data interfaces. Requirements : Ability to work within a team environment and build relationships outside of the department as well as outside the company. Proven ability to direct, build, develop and manage a team of professionals. Ability to deal with difficult situations with tact, professionalism, and discretion. Demonstrate technical expertise and aggressiveness. Ability to work with minimum supervision and consider options to complete quality work. Proficient in personal computer skills including electronic mail, project management, record keeping, and routine database activity, word processing, spreadsheet, etc. Eligibility : Minimum of 2 years of hands-on experience with Python and SQL Educational qualification: B.Tech in Computer Science, BCA, or MCA Proficient in business communication, with excellent verbal and written English skills Prior knowledge of ETQ Script and ETQ Web Services would be a significant advantage
Responding to escalated customer issues from L1 Customer Support Specialists. Excellent communication skills, especially related to relaying information between technical and non-technical parties Working closely with support and Level 3 teams. Building a deep technical knowledge of our product capabilities for both the front and back end. Escalating issues when required according to defined escalation paths. Maintaining a high level of professionalism with internal teams and customers and working to establish a positive rapport. Participation in standard product management processes (grooming sessions, stand-ups, etc. ) related to the resolution of customer-facing issues Work continuously to document product and technical knowledge. Responsible for driving L2 and L3 cases to closure meeting "case to closure" and "customer satisfaction" deliverables Skills:- Python, SQL, Amazon Web Services (AWS), Customer Support and Quality management
We are seeking a skilled Computer System Validation (CSV) Specialist to join our team and assist clients in validating quality management system (QMS) software within the life sciences industry. Your main focus will be to ensure that the QMS software solutions meet regulatory requirements and industry standards, supporting clients in achieving compliance with Good Manufacturing Practices (GMP), FDA, EMA, and other applicable regulations. This client-facing role requires strong technical expertise, regulatory knowledge, and excellent communication skills. In this role, your responsibilities will include leading the validation of QMS software for clients, encompassing planning, execution, and documentation of validation activities. You will develop and review validation deliverables such as Validation Plans (VP), User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Traceability Matrices (RTM), Test Protocols (IQ/OQ/PQ), and Validation Reports (VR). Additionally, you will guide clients through the validation process to ensure compliance with regulatory standards such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. You will conduct risk assessments for computerized systems to identify potential compliance gaps and provide recommendations for mitigating risks related to data integrity, security, and system functionality. Moreover, you will train client teams on validation processes, regulatory requirements, and best practices for maintaining validated systems. Developing Standard Operating Procedures (SOPs) and work instructions for clients to support ongoing system use and compliance will also be part of your responsibilities. As a CSV Specialist, you must stay updated on regulatory changes in the life sciences industry and advise clients on how these changes impact their QMS software validation efforts. Guiding data integrity principles and ensuring alignment with industry standards is crucial for this role. To qualify for this position, you should hold a Bachelor's degree in Life Sciences, Engineering, Computer Science, or a related field. A Master's degree is considered a plus. A minimum of 2 years of experience in computer system validation within the life sciences industry is required, along with experience in QMS software implementation. A proven track record of working with regulatory frameworks such as FDA 21 CFR Part 11, EU Annex 11, GAMP 5, or ISO 13485 is essential. In terms of technical skills, you should have a strong understanding of validation methodologies and documentation requirements for computerized systems. Familiarity with leading QMS software platforms such as ETQ Reliance, MasterControl, Veeva Vault QualityDocs/Quality Suite, TrackWise Digital, or similar tools is advantageous. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and project management tools is also required. Soft skills are equally important for this role, including excellent written and verbal communication skills to interact effectively with clients at all levels of an organization. Strong problem-solving skills and the ability to manage multiple projects simultaneously under tight deadlines are essential qualities for success in this position.,