Amneal Pharmaceuticals Hiring Executive CSV Quality in Ahmedabad. Apply now for Computer System Validation jobs in Gujarat pharma sector.
Position: Executive – CSV (Computer System Validation)
Company: Amneal Pharmaceuticals
Location: Ahmedabad, Gujarat, India
Qualification: B.Pharm / M.Pharm
Experience: 2–6 Years (preferred)
Employment Type: Full-Time
Industry: Pharmaceutical / Quality Assurance / Validation
Application Mode: Online
About Amneal Pharmaceuticals
Amneal Pharmaceuticals is one of the fastest-growing global pharmaceutical companies, renowned for manufacturing high-quality generic and specialty medicines. With a strong presence in the Indian and international markets, Amneal is committed to innovation, quality, and patient safety. Amneal Pharmaceuticals Hiring Executive CSV
Headquartered in Bridgewater, New Jersey, Amneal operates modern manufacturing facilities across India, including its world-class plant in Ahmedabad, Gujarat. The company adheres to global regulatory standards such as US FDA, MHRA, and EU GMP, ensuring compliance and excellence in every product it delivers. Amneal Pharmaceuticals Hiring Executive CSV
At Amneal, employees are part of a culture that values collaboration, continuous improvement, and integrity. The company believes in empowering professionals through learning and development, enabling them to grow their careers in a dynamic pharmaceutical environment. Amneal Pharmaceuticals Hiring Executive CSV
About the Role: Executive – CSV (Computer System Validation)
Amneal Pharmaceuticals is currently hiring an Executive – CSV (Quality) for its facility in Ahmedabad, Gujarat.
This position is a key role within the Quality Assurance department, responsible for ensuring the validation and compliance of computerized systems used in manufacturing, laboratory, and quality operations. Amneal Pharmaceuticals Hiring Executive CSV
The CSV Executive will be involved in validation activities for GxP systems, ensuring adherence to regulatory requirements such as 21 CFR Part 11, EU Annex 11, and MHRA guidelines. The role demands both technical and regulatory expertise, as it bridges IT, QA, and manufacturing teams to maintain validated and compliant computerized environments. Amneal Pharmaceuticals Hiring Executive CSV
Key Job Responsibilities
As an Executive – Computer System Validation (CSV), your primary responsibilities will include: Amneal Pharmaceuticals Hiring Executive CSV
- Review and Approval of Validation Deliverables:
Review key CSV documents including Validation Plans, User Requirements (URS), Functional Specifications (FS), Risk Assessments, IQ/OQ/PQ Protocols, Traceability Matrices, and Validation Summary Reports to ensure accuracy and regulatory compliance. - System Risk Assessments:
Perform thorough system risk assessments to determine GxP impact, data integrity risks, and the required level of validation for computerized systems. - Qualification Testing:
Review and oversee Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing to ensure systems function as intended under controlled conditions. - Regulatory Compliance:
Ensure compliance with international regulatory standards, including FDA 21 CFR Part 11, EU Annex 11, MHRA guidelines, ICH Q7, and ICH Q9. - Audit Support:
Provide support during internal audits, client inspections, and regulatory inspections by maintaining comprehensive and compliant validation documentation. - Cross-Functional Collaboration:
Collaborate closely with teams from IT, Manufacturing, QA, and Business Operations to ensure seamless validation and lifecycle management of critical GxP systems such as ERP, LIMS, MES, CDS, and QMS. - Documentation and Record Management:
Maintain all validation-related documentation in accordance with company SOPs, data integrity requirements, and good documentation practices (GDP). - Change Control & CAPA Management:
Participate in Change Control, Deviation, and CAPA management processes related to computerized systems. Ensure all system modifications are validated as per global compliance standards. - Training and Guidance:
Provide technical training to cross-functional teams on CSV processes, lifecycle documentation, and data integrity best practices. - Transition to CSA Approach:
Contribute to the organization’s strategic shift from CSV (Computer System Validation) to CSA (Computer Software Assurance), aligning with the latest FDA guidance for risk-based software validation.
Technical Skills Required
- CSV Lifecycle Management – Advanced knowledge of validation lifecycle documentation including URS, FS, RA, IQ/OQ/PQ, and VSR.
- GAMP 5 Guidelines – Deep understanding of risk-based validation principles and lifecycle management per GAMP 5.
- Regulatory Compliance Expertise – Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, and data integrity guidelines.
- SDLC (System Development Life Cycle) – Ability to manage system development and validation within structured SDLC methodologies.
- Computer Software Assurance (CSA) – Exposure to the latest CSA principles for risk-based system assurance and testing efficiency.
- Validation Documentation Proficiency – Expertise in writing and reviewing validation deliverables, audit trails, and summary reports.
Educational Qualification
- Required: B.Pharm or M.Pharm from a recognized university.
- Preferred: Candidates with additional certifications in CSV, GAMP5, or Quality Systems will be given preference.
Experience Required
- Minimum 2 to 6 years of experience in CSV, QA Validation, or Computerized Systems in Pharma or Biotech industries.
- Hands-on experience in the validation of ERP, LIMS, MES, CDS, QMS, or other GxP-compliant systems.
- Experience supporting regulatory audits and ensuring data integrity compliance is highly desirable.
Core Competencies
- Strong analytical and problem-solving skills.
- Attention to detail and precision in documentation.
- Excellent interpersonal and communication abilities.
- Capability to work independently as well as within cross-functional teams.
- Adaptability to changing technologies and global compliance trends.
- Sound understanding of GxP principles and validation lifecycle.
Why Join Amneal Pharmaceuticals
Amneal Pharmaceuticals offers an inspiring and inclusive work environment where employees are encouraged to innovate and excel. As an Executive in CSV, you will have the opportunity to work with advanced technologies and contribute to the company’s mission of delivering quality medicines worldwide. Amneal Pharmaceuticals Hiring Executive CSV
Benefits of Joining Amneal:
- Competitive salary with performance-linked incentives.
- Exposure to global regulatory standards and practices.
- Opportunities for professional growth and continuous learning.
- A collaborative culture that promotes work-life balance.
- Involvement in digital transformation initiatives such as Computer Software Assurance (CSA).
About the Team
The Quality Assurance and Human Resources teams at Amneal work in tandem to foster a compliant, efficient, and empowering workplace. Amneal Pharmaceuticals Hiring Executive CSV
The Human Resources team plays multiple roles:
- Executive Role: Provides strategic input in workforce planning and business decisions.
- Audit Role: Ensures legal and ethical compliance across employment policies.
- Facilitator Role: Strengthens talent acquisition, training, and performance management initiatives.
- Consultancy Role: Offers expert advice on employee relations and workforce development.
- Service Role: Keeps the organization aligned with labor market trends and legislative changes.
Together, these teams ensure Amneal remains a Great Place to Work for professionals who aim to build impactful careers in the pharmaceutical industry. Amneal Pharmaceuticals Hiring Executive CSV
Work Location
- City: Ahmedabad
- State: Gujarat, India
- Work Mode: On-site / Full-time
How to Apply
Interested and eligible candidates can apply online through the official Amneal Pharmaceuticals Career Portal or send their resume to the company’s HR department. Amneal Pharmaceuticals Hiring Executive CSV
Steps to Apply Online:
- Visit the official Amneal careers page: https://www.amneal.com/careers
- Search for the job title “Executive – CSV (Quality)” or use relevant filters for location: Ahmedabad.
- Review the full job description carefully.
- Click on “Apply Now” and log in or register on the portal.
- Fill in your professional details and upload your updated resume.
- Submit your application before the deadline.
Alternatively, you can email your resume directly to the Amneal HR Department with the subject line:
“Application for Executive – CSV (Quality), Ahmedabad.”
Conclusion
If you are passionate about pharmaceutical quality systems, computer validation, and regulatory compliance, this is the perfect opportunity to join a global leader like Amneal Pharmaceuticals. Amneal Pharmaceuticals Hiring Executive CSV
The position of Executive – CSV (Quality) offers the chance to work on advanced validation projects, participate in global audits, and contribute to the company’s continuous improvement initiatives.
Take the next step in your pharmaceutical career—apply today and be part of Amneal’s journey toward innovation, compliance, and excellence. Amneal Pharmaceuticals Hiring Executive CSV
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