Lonza is hiring for a Senior QA Specialist โ QA Documentation position in Hyderabad, India. This is an excellent opportunity for experienced professionals in Quality Assurance, GMP documentation, document lifecycle management, data integrity, and GxP compliance.
The selected candidate will join Lonza’s Quality Systems & Compliance team and play a critical role in the compliant management, oversight, retention, archiving, and disposition of GMP-relevant documentation.
The Lonza QA Documentation job in Hyderabad involves managing the complete lifecycle of quality records, overseeing archiving activities, supporting True Copy Scanning, ensuring documentation integrity, and making compliance-based decisions regarding document retention and destruction.
Professionals with experience in QA documentation, GMP quality systems, data integrity, Annex 11, and 21 CFR Part 11 may find this opportunity particularly relevant.
Job Highlights
- Company: Lonza
- Job Title: Senior QA Specialist โ QA Documentation
- Department: Quality Systems & Compliance
- Job Requisition ID: R75352
- Location: Hyderabad, India
- Employment Type: Full-Time
- Experience: Experience in QA or Documentation Management required
- Industry: Pharmaceutical / Biotechnology / Life Sciences
- Primary Skills: GMP, GxP, QA Documentation, Data Integrity, Document Lifecycle Management
- Posted: September 9, 2026
About the Lonza QA Documentation Role
The Senior QA Specialist โ QA Documentation will be responsible for the compliant management and oversight of quality documentation throughout its lifecycle.
The role focuses on ensuring that GMP-relevant documents are properly managed from finalization through archiving, customer dispatch, retention, or destruction.
The QA specialist will also act as a key decision-maker for documentation lifecycle activities and serve as the QA representative for archiving processes.
A significant component of the role involves managing and improving the True Copy Scanning process, including maintaining related Standard Operating Procedures (SOPs), ensuring process compliance, and providing training to employees involved in scanning and documentation workflows.
Key Responsibilities
1. Document Management and QA Oversight
The selected candidate will provide Quality Assurance oversight for GMP and quality-relevant documentation.
Key responsibilities include:
- Ensuring compliant management of quality-relevant documents.
- Managing documentation from finalization through dispatch, archiving, retention, or destruction.
- Ensuring compliance with internal Standard Operating Procedures (SOPs).
- Providing QA oversight for documentation processes.
- Maintaining documentation integrity and traceability.
- Ensuring compliance with GMP archiving requirements.
- Supporting regulatory and customer requirements.
- Reviewing the lifecycle and disposition of archived documentation.
- Making decisions regarding customer delivery or destruction of documents.
- Collaborating with QA Operations and document owners.
2. Manage the True Copy Scanning Process
The Senior QA Specialist will play a key role in the management and continuous improvement of the True Copy Scanning process.
Responsibilities include:
- Owning and maintaining the True Copy Scanning process.
- Optimizing documentation scanning workflows.
- Creating and revising related SOPs.
- Conducting periodic reviews of procedures.
- Ensuring compliance with regulatory requirements.
- Aligning scanning processes with internal quality standards.
- Improving process efficiency.
- Providing specialized training to employees.
- Supporting employees involved in scanning and documentation workflows.
- Managing system access rights.
- Ensuring appropriate segregation of duties within documentation systems.
3. GMP Archiving and Documentation Lifecycle Management
The role requires strong knowledge of GMP document lifecycle management and archiving requirements.
Responsibilities include:
- Acting as the QA representative for archiving activities.
- Serving as the main QA contact for external archiving service providers.
- Ensuring third-party archiving activities comply with Lonza standards.
- Managing GMP documentation exceeding defined retention periods.
- Evaluating whether documents should be destroyed or dispatched to customers.
- Collaborating with internal stakeholders on document disposition decisions.
- Maintaining compliance throughout the document lifecycle.
4. Retain Samples Disposition
The QA Documentation Specialist will also support compliant decision-making related to retain samples.
Responsibilities include:
- Evaluating retain samples that exceed defined retention periods.
- Collaborating with QA Operations.
- Coordinating with project owners.
- Supporting compliant decisions regarding sample disposition.
- Ensuring appropriate documentation of decisions and outcomes.
Required Qualifications and Skills
Lonza is seeking professionals with experience in Quality Assurance and Documentation Management within highly regulated environments.
Essential Experience
Candidates should have experience in:
- Quality Assurance
- QA Documentation
- Documentation Management
- GMP environments
- GxP-regulated environments
- Quality Systems
- Document lifecycle management
- Document archiving
Technical Knowledge
Candidates should have a strong understanding of:
- GMP requirements
- GxP regulations
- Data Integrity principles
- GMP archiving requirements
- Documentation retention requirements
- Document destruction procedures
- Annex 11
- 21 CFR Part 11
- Quality documentation systems
- Standard Operating Procedures (SOPs)
Knowledge of electronic records, documentation integrity, and regulated computerized systems will be valuable for this role.
Professional Skills
The ideal candidate should demonstrate:
- Strong decision-making abilities
- Risk assessment skills
- Excellent attention to detail
- Strong organizational abilities
- Documentation management skills
- Effective communication skills
- Stakeholder management
- Cross-functional coordination
- Ability to work with external service providers
- Ability to manage complex retention schedules
Language Requirements
- English: Required, written and spoken.
- German: Considered an advantage.
Who Should Apply?
This Lonza QA Documentation job in Hyderabad may be suitable for professionals working in:
- Quality Assurance
- QA Documentation
- GMP Documentation
- Quality Systems
- GxP Compliance
- Data Integrity
- Document Control
- Records Management
- GMP Archiving
- Pharmaceutical Quality
- Biotechnology Quality
Candidates with experience managing SOPs, GMP records, document retention schedules, electronic documentation, and regulated quality systems may be particularly relevant for this position.
Benefits of Working at Lonza
Lonza highlights several professional and workplace benefits for employees.
Key Benefits Include:
- Agile career opportunities
- Dynamic working culture
- Inclusive workplace
- Ethical work environment
- Performance-based compensation programs
- Opportunity to manage critical compliance processes
- Exposure to True Copy Scanning processes
- Professional growth opportunities
- Access to a globally connected Quality network
- Opportunities to work with international teams
- Career development within the global life sciences industry
Lonza also offers additional employee benefits through its global benefits programs.
About Lonza
Lonza is a global life sciences organization supporting the development and manufacturing of medicines and therapies.
With more than 30 sites across five continents, Lonza’s globally connected teams collaborate to help transform scientific ideas and customer innovations into viable therapies.
The organization emphasizes the following core values:
- Collaboration
- Accountability
- Excellence
- Passion
- Integrity
Lonza operates across the pharmaceutical, biotechnology, and life sciences ecosystem and provides opportunities for professionals working in manufacturing, quality, regulatory compliance, and scientific development.
Salary for Senior QA Specialist โ QA Documentation
Lonza has not disclosed the official salary for Job Requisition R75352.
Based on comparable Senior QA Specialist and QA Documentation roles in Hyderabad’s pharmaceutical and biotechnology industry, the estimated annual salary range may be:
Estimated Salary: โน8,00,000 โ โน15,00,000 per annum
Note: This is an editorial estimate based on comparable roles and is not an official Lonza salary disclosure. Actual compensation may depend on experience, qualifications, technical expertise, internal compensation structures, and other factors.
Candidates should confirm compensation details during the recruitment process.
How to Apply
