Telangana Author Jobs – 135 Open Jobs Today

Quality & Validation Lead
Opella Healthcare Group —Hyderabad, Telangana
- Full-time
- Computer Science
- Engineering
- Master's degree
10d
Global Regulatory Writing – Senior Manager
Amgen —Hyderabad, Telangana
- Doctoral degree
- Word processing
- Writing skills
Sr Associate Product Quality - Analytical
Amgen —Hyderabad, Telangana
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
6d
Epidemiology Analyst
Amgen —Hyderabad, Telangana
- Medicine
- Doctoral degree
- Research
Internal Job Posting-Software Engineer - III
FactSet Research Systems —Hyderabad, Telangana
- Full-time
- Computer Science
- System design
- Java
14h
Assistant Managing Editor
Pulsus Group —Hyderabad, Telangana
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Staff engineer , ASIC AMS Verification
Micron —Hyderabad, Telangana
- B.Sc
- Master's degree
- Bachelor's degree
9d
Executive - DQA
Piramal Pharma Limited —Digwal, Telangana
- Full-time
- Master's degree
- APIs
2d
Associate Director, Biostatistics
Bristol-Myers Squibb —Hyderabad, Telangana
- Email
- Hybrid work
- Doctoral degree
- Project management
- Travel
OpEx Manager
Reckitt —Hyderabad, Telangana
- Project management
- Bachelor's degree
- Mentoring
- Health insurance
14d
Senior Manager Medical Review
Regeneron —Hyderabad, Telangana
- Medicine
- Bachelor's degree
- AI
- Health insurance
- Paid time off
Product Owner
Kensium —Hyderabad, Telangana
- Full-time
- Azure
- Salesforce
- DevOps
Sr Associate Clinical Supply chain - NAMP Planner / Buyer
Amgen —Hyderabad, Telangana
- Microsoft Excel
- ERP systems
- English
Senior Revenue Cycle Specialist - Work From Home
ClinicMind —Hyderabad, Telangana
- Remote
- Microsoft Excel
- English
- Finance
- Work from home
Quick apply
Senior Associate Endpoint Security Engineer
Amgen —Hyderabad, Telangana
- Computer science
- Windows
- Master's degree
9d
Business Analyst
Cambridge Technology Enterprises (CTE) —Hyderabad, Telangana
- Full-time
- Microsoft Outlook
- Microsoft Office
- Databases
Biostatistics Sr Associate – Data Visualization
Amgen —Hyderabad, Telangana
- Doctoral degree
- English
- Master's degree
Senior Developer, Platform Engineer
Intercontinental Exchange Holdings, Inc. —Hyderabad, Telangana
- Full-time
- Azure
- AWS
- Scripting
Staff/Principal Engineer - AI/ML & System-Level Validation
Advanced Micro Devices, Inc —Hyderabad, Telangana
- Doctoral degree
- Computer Science
- B.Sc
React Developer with .Net
Verisk —Hyderabad, Telangana
- Full-time
- Azure
- Computer Science
- Software troubleshooting

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Quality & Validation Lead

Opella Healthcare Group -
Hyderabad, Telangana

Apply Now

Job details

Full-time
10 days ago

Qualifications

Jira
Computer Science
Software deployment
Engineering
Master's degree
Bachelor's degree
Confluence
Scrum
Agile

Full job description

Job title : Qualification & Validation Lead

Location : Hyderabad

About Opella

Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people' s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting.

Headquartered in France, Opella is the proud maker of many of the world' s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com .

About the role

The Qualification & Validation Lead — Shall act as a Business Quality Representative (BQR) for various enterprise projects in the Computerized Systems Compliance domain within the GxP area. This role takes responsibility for ensuring adherence to the global validation processes, coherent application of Opella's Validation & Qualification requirements. He/ She shall serve as a Subject Matter Expert (SME) and act as key link between Local Process Owners (LPOs) and Global Quality, providing guidance and active support for IT Systems rollout, maintenance, and qualification activities.

This role also authors various domain related standards, procedures and workflows.

Execute the corporate business strategy in the area of responsibility, With this respect the incumbent is responsible for streamlining operational processes, mutualizing execution activities, and ensuring cross-regions key learnings and good practices sharing and related communication to contribute to agility in execution.

Main Responsibilities

CSV Strategy & Governance

Develop and implement Computerized System Validation (CSV) strategies aligned with regulatory requirements.
Ensure compliance with GxP, 21 CFR Part 11, EU Annex 11, and data integrity principles.
Maintain and improve CSV frameworks, policies, and procedures.
Guide the Q & V teams on validation aspects of Digital Applications, to ensure compliance to requirements of data integrity and applicable regulations.

Business Quality Representative:

Act as BQR to Oversee validation of various enterprise applications used in GxP domain such as:

Laboratory systems (LIMS, CDS)

Manufacturing systems (MES, SCADA)

Quality systems (eQMS)

ERP and supporting GxP systems

Training & Content Management Systems

Serialization and Regulatory Information systems

Approve validation deliverables and documentation.

Apply risk-based validation approaches (GAMP 5).

Q&V Support:

Partner with:

Digital teams for system implementation and changes

Business process owners

Technical system owners Business owners for system requirements

Provide CSV guidance for projects, upgrades, and system changes .

Mentor team members and stakeholders on best practices. Review and update the Global Quality documents pertaining to processes for Q & V in alignment with the applicable emerging regulatory requirements.

Drive simplification, standardization, and continuous improvement in validation processes.

Be the SME for Q & V and support QA teams to prepare for regulatory inspections, answer any queries raised by the Inspectors and work out CAPA to close any gaps identified by the Inspectors.

Required Qualifications

Education

Bachelor's or master’s in engineering, Computer Science, Pharmacy, Life Sciences or related field,

Experience

Minimum 10 years of progressive experience in handling CSV in Pharma/ Nutraceutical domain. Must have experience in handling enterprise level projects for deployment of GxP applications.

Q&V

Advanced knowledge of Computerized System Validation (CSV), GAMP, Computerized System Assurance (CSA), Data Integrity (ALCOA+), Quality Management Systems (QMS), GxP regulations and compliance (USFDA, MHRA, TGA etc.)

Agile & Data

Familiarity with Scrum/Agile, Jira, and Confluence; comfort with KPI tracking and reporting tools.

Skills & Profile

Proactive and autonomous — able to manage multiple priorities in a global, matrixed organization.

Strong decision-making and problem-solving

Effective communication and influence

Ability to work cross-functionally

Results-driven mindset with attention to detail & genuine curiosity for Q&V topics, Operations, Quality systems, Science.

Why us?

At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.

We Are Challengers.

We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:

All In Together: We keep each other honest and have each other's backs.

Courageous: We break boundaries and take thoughtful risks with creativity.

Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.

Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.

Join us on our mission. Health. In your hands.

www.opella.com/en/careers

Apply Now

Refine Your Search

author jobs in telangana

Quality & Validation Lead

Global Regulatory Writing – Senior Manager

Sr Associate Product Quality - Analytical

Epidemiology Analyst

Internal Job Posting-Software Engineer - III

Assistant Managing Editor

Staff engineer , ASIC AMS Verification

Executive - DQA

Associate Director, Biostatistics

OpEx Manager

Senior Manager Medical Review

Product Owner

Sr Associate Clinical Supply chain - NAMP Planner / Buyer

Senior Revenue Cycle Specialist - Work From Home

Senior Associate Endpoint Security Engineer

Business Analyst

Biostatistics Sr Associate – Data Visualization

Senior Developer, Platform Engineer

Staff/Principal Engineer - AI/ML & System-Level Validation

React Developer with .Net

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