QA Associate

3 days ago

HITEC City Hyderabad Telangana, India AmpleLogic Full time

**About AmpleLogic**
- We're a trusted provider of GAMP solutions, specializing in empowering the life sciences industry through our advanced Application Platform as a Service (aPaaS) platform. Since 2010, AmpleLogic has been dedicated to developing industry-standard solutions that are effective, efficient, and competitive. With over 12 products deployed, including eQMS, LMS, DMS, and more, we have served 100+ life science companies worldwide. Our flagship product, eQMS, reflects our commitment to quality, compliance, and innovation._

We’re seeking a detail-driven **QA professional** with **B.Tech/BE/M.Tech** educational background having **3-4 years of hands-on experience** in **Computerized System Validation (CSV), 21 CFR Part 11, GAMP 5 and EU Annex 11.**

**Roles and Responsibilities will include: -**
- Review new processes and changes, capture lessons and best practices from audited projects to suggest process improvements at the organizational level and implement new processes as per process and change improvements received from employees.
- Ensure all project documentation is available in, create process-related documentation, maintain audit records in, and perform documentation reviews as per standards
- Conduct deliverable audits, baseline audits, internal quality audits, and external audit assessments, facilitate closure of audit/assessment findings, and complete assessments of internal LMS on time
- Handle QA roles for at least 10 projects within 5 months, complete induction and role-specific training as per schedules, and take feedback to improve the induction training mechanism
- Control code release mechanisms, manage temporary roles for closing pending action items on behalf of exited employees, and ensure action items entry for recording of actual time spent in carrying out of project activities
- Ensure the final product meets the company's quality standards as a quality assurance executive
- Ensure compliance of our software is up to date, follow proper escalation and notification mechanisms to address issues, and respond to issues related to software/LMS posted by users on a priority basis
- Create forms and make changes existing forms and workflows, and provide support as required
- Stabilise processes according to the SDLC delivery model followed in the organisation
- Make policies updated as per the latest practices followed within the premises, and schedule training to ensure compliance.

**Job Types**: Full-time, Permanent

Pay: ₹600,000.00 - ₹1,000,000.00 per year

**Benefits**:

- Flexible schedule
- Health insurance
- Leave encashment
- Life insurance
- Paid sick time
- Paid time off
- Provident Fund

Schedule:

- Day shift

Work Location: In person

**Speak with the employer**
+91 7076925831

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