Get AmbitionBox App
Faster and better experience!
AmbitionBox
Jobs
- Reviews
- Salaries
- Interview Questions
- About Company
- Benefits
- Jobs
- Office Photos
- Community
Add office photos
All Filters
7 AmpleLogic Jobs
Quality Assurance Manager
AmpleLogic
posted 2d ago
Job Description
- Good understanding of the GAMP 5, 21 CFR Part 11, EU GMP Annex 11, ICH Quality and other regulatory guidelines
- Review requirements, specifications, and technical design documents to provide timely and meaningful feedback.
- Experience in Validation life cycle of regulated projects GxP Awareness including Good Documentation.
- Practice Knowledge on Change control and Deviations, GAMP Categorization, Protocol Preparation, Vendor Evaluation.
- Good knowledge on pharma regulatory compliance processes and regulations
- Ensure all defined Process Engineering phases are reviewed, verified & defect removal is done.
- Take responsibility for creating the Project Validation Plan based on the criticality of the proposed system, in consensus with the vendor, based on their Quality Systems.
- Performing Internal Audits as per annual inspection plan for GxP/GMP compliance and quality review.
- Capture the lessons and best practices in projects and suggest process improvements at the organization level.
- Conduct process related trainings and its tracking.
- Practice on Review for Requirement Specifications. (URS,FS and DS)
- Ensure that all sources are baseline and stored centrally in the central repository and local library of the project.
- Conduct baseline audits and reviews.
- Troubleshooting / investigating project defect database and bugs are classified.
- Establishing and implementing corrective and preventive actions and process improvements initiatives for CSV projects.
- Experience in SDLC phases & Software Release strategy.
- Candidate should have work experience in software & Pharma industry.Role & responsibilities
Employment Type: Full Time, Permanent
Read full job descriptionPrepare for Manager Quality Assurance roles with real interview advice
What people at AmpleLogic are saying
What AmpleLogic employees are saying about work life
based on 99 employees
Strict timing
Monday to Friday
No travel
Day Shift
AmpleLogic Benefits
View more benefits
Compare AmpleLogic with
Sarjen Systems
Compare
Coral Healthcare
Compare
Innovative Informatics
Compare
Medi Assist India
Compare
Yalamanchili Software Exports
Compare
Trawex Technologies
Compare
ScoreMe Solutions
Compare
Xtancia Technosoft
Compare
Global Edge Software
Compare
Ichhapurti.com
Compare
Logelite
Compare
Volksoft Technologies
Compare
WovVTech
Compare
Pagarbook
Compare
Virtual Galaxy Infotech
Compare
Moveinsync Technology Solutions
Compare
Atidan Technologies
Compare
KDK Software
Compare
StrategicERP
Compare
SurePrep
Compare
Recently Viewed
Share an Interview
How was your last interview experience?
Feedback
