Global Opportunities to Join the Celegence Team
At Celegence, you have the opportunity to shine and truly make a difference. We have a growing organization where your inputs will be valued. We have roles for all levels; both recent graduates and experienced professionals. We are currently looking for applicants with the following backgrounds. Celegence offers competitive compensation and benefits, growth opportunities, and a supportive work environment.
Celegence is an Equal Employment Opportunity Employer
All employment decisions at Celegence are made without regard to age, race, creed, colour, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Celegence is committed to providing a positive work environment as a part of the core Organizational value and is free from discrimination and harassment, and we will not tolerate any form of unlawful discrimination or harassment.
Why work at Celegence?
Be a part of a remarkable journey!
Collaborative Team
Here at Celegence, you get a great team that always stands by you.
Supportive Manager
A supportive Manager who makes sure you are absolutely comfortable with the work you’re doing.
HR team
An amazing HR team who is always working up different ways to keep the employees motivated (also by sending lovely goodies every now and then).
Leadership Team
Here you get the best leadership team that is equally concerned about employee’s career growth as they are about the development of this organization.
- Bangalore
- Onsite, Hybrid
- Reporting to Associate Director - QA
Celegence LLC is a privately owned consulting organization headquartered in Chicago, Illinois (USA), with offices across the UK, Europe and India. The company specializes in Regulatory Affairs consulting services and technology solutions for the global Life Sciences industry.
Our experienced professionals support organizations in managing day-to-day regulatory operations by ensuring global compliance, applying deep industry expertise and leveraging technology and automation to improve operational efficiency.
Our vision is to become the premier niche provider of regulatory services and innovative solutions, enabling life science organizations to deliver exceptional patient value through end-to-end regulatory excellence.
Qualification
M.Sc. or M. Pharma
- ISO 9001:2015 Standards
- QMS Document Management
- Audit Management
- Change Management
- CAPA Management
- Vendor Management
- Strong communication skills (verbal and written)
- Analytical thinking and problem-solving ability
- Effective stakeholder collaboration and teamwork
- Time management with the ability to handle multiple priorities
- Strong knowledge of ISO 9001:2015 standards and Quality Management System (QMS) processes.
- Audit Management including planning, execution and closure.
- Corrective and Preventive Action (CAPA) Management.
- Document Control and Change Management within the Quality Management System.
Integrity
High level of integrity with a strong ethical mindset.
Ownership
Strong ownership, accountability and commitment to quality.
Detail-Oriented
Focused on quality, compliance and continuous attention to detail.
Continuous Improvement
Proactive attitude with a continuous improvement mindset and willingness to innovate.
- Document Control & Management
- Maintain and update QMS documents including creation, review and revision in line with ISO standards.
- Manage complete document lifecycle including version control and archival.
- Review SOPs, Policies, Manuals and Work Instructions for accuracy and compliance.
- Ensure periodic review and timely revision of documents.
- Prepare and publish quarterly QMS reports with key metrics and insights.
- Audit & Compliance
- Schedule and coordinate internal audits as per the approved audit plan.
- Conduct internal audits and document findings.
- Share audit outcomes with Project Managers and Delivery Heads.
- Support external audit preparation and readiness activities.
- Track and ensure timely closure of audit findings.
- Project Management Support
- Maintain and update the Global Project Tracker.
- Ensure project documentation remains complete and audit ready.
- Verify project-specific risk assessments.
- Track mitigation and contingency plans.
- Support adherence to customer-specific QMS requirements.
- Change Management
- Coordinate with Cross Functional Teams to manage Change Requests.
- Track Change Request lifecycle and closure.
- Review Change Requests for completeness, risk and impact assessment.
- Ensure proper risk analysis before approvals.
- Vendor & Risk Management
- Maintain and update the Approved Vendor List.
- Ensure vendor documentation is complete and available.
- Track vendor evaluation and re-evaluation activities.
- Maintain department risk assessment trackers.
- Support mitigation and contingency planning.
- CFT Support & Training
- Ensure adherence to QMS processes across functions.
- Track action items and follow up for timely closure.
- Conduct monthly QA discussions with functional teams.
- Provide QMS training and awareness sessions.
- Promote collaboration between QA and Cross Functional Teams.
- Continuous Improvement & Innovation
- Drive adoption of QMS tools and workflow automation.
- Reduce manual dependency and improve data accuracy.
- Track quality, efficiency and compliance improvement metrics.
- Identify process improvement opportunities.
- Promote continuous improvement and operational excellence.
- Improve document control efficiency and traceability using automation tools.
