Manager, Quality Assurance – R&D Digital Transformation

Amneal Career Sites
Apply Now ↗
📍 Ahmedabad City, Gujarat, IndiaFull time

About this role

Job Description:

  • Review product development strategies to ensure compliance with current regulatory requirements, industry expectations, and quality standards. 

  • Review formulation development reports to verify data integrity, traceability, accuracy, and compliance with laboratory notebooks, raw data, and supporting documents.  

  • Manage issuance, control, reconciliation, and maintenance of laboratory notebooks and associated records. Coordinate with Formulation Development, Analytical Development, Regulatory Affairs, and other cross-functional teams for preparation and review of scientific responses to regulatory queries, including USFDA Screening Queries, Information Requests (IR), ECD/EDL communications, Complete Response Letters (CRL), and other agency communications. 

  • Provide quality assurance inputs in Design Space and Quality by Design (QbD) activities to strengthen development reports and regulatory submissions. 

  • Develop and maintain a database of regulatory deficiencies, agency responses, historical observations, and anticipated queries to support robust development strategies. 

  • Review and approve development-related documentation to ensure compliance with internal procedures and applicable regulatory requirements. 

  • Review documents related to instrument qualification, calibration, maintenance, and equipment lifecycle management as required. 

  • Control issuance, review, revision, and archival of formulation development documents and records.

  • Monitor archival, retention, retrieval, and management of departmental documents in accordance with company procedures. 

  • Act as the departmental coordinator for Quality Management Systems (QMS), including Cliber, AIMS, DMS, and other electronic quality systems.

  • Provide QA oversight and support for packaging development activities whenever required. 

  • Ensure adherence to Data Integrity, Good Documentation Practices (GDP), Quality Systems, and applicable regulatory expectations.

  • Promote and enforce the organization's Code of Conduct, quality culture, ethics, safety, hygiene, and compliance standards across the department.

  • Support inspection readiness and participate in internal, customer, and regulatory audits as required. Collaborate with cross-functional teams to identify quality risks and implement appropriate corrective and preventive actions.

  • Drive continuous improvement initiatives related to development quality systems, documentation practices, and regulatory compliance.

  • Proficiency in Microsoft PowerPoint for preparation of professional scientific, quality, regulatory, and management presentations.

  • Strong digitalization mindset with experience in electronic quality systems, digital workflows, process automation, data analytics, and dashboard development (Power BI, Excel advanced analytics, or similar tools preferred).

  • Effective communication, presentation, and stakeholder management skills.

 

Education:

  • B. Pharm M. Pharm - Required
  • Ph. D. Ph. D. - Preferred

Experience:

  • 15 years or more in 15+ Years

Specialized Knowledge: Licenses:

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

Frequently Asked Questions

Is the salary disclosed for the Manager, Quality Assurance – R&D Digital Transformation position at Amneal Career Sites?
The salary for this Manager, Quality Assurance – R&D Digital Transformation role at Amneal Career Sites is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Manager, Quality Assurance – R&D Digital Transformation position at Amneal Career Sites located?
This Manager, Quality Assurance – R&D Digital Transformation role at Amneal Career Sites is based in Ahmedabad City, Gujarat, India. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Manager, Quality Assurance – R&D Digital Transformation role at Amneal Career Sites full-time or part-time?
This is listed as a Full time position. It is posted as a Manager, Quality Assurance – R&D Digital Transformation role at Amneal Career Sites.
How do I apply for the Manager, Quality Assurance – R&D Digital Transformation position at Amneal Career Sites?
Click the "Apply Now" button on this page. You will be redirected to Amneal Career Sites's official application portal hosted on oraclecloud where you can submit your application directly.
When was the Manager, Quality Assurance – R&D Digital Transformation job at Amneal Career Sites posted?
This Manager, Quality Assurance – R&D Digital Transformation position at Amneal Career Sites was posted on Sep 22, 2026. Apply as soon as possible — early applications are often reviewed first.
Manager, Quality Assurance – R&D Digital Transformation
Amneal Career Sites
Apply for this role ↗

You'll be redirected to Amneal Career Sites's official application page on oraclecloud.