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.
- Perform any additional responsibilities assigned by the Head of Department (HOD) in line with organizational and departmental objectives.
Education:
- B. Pharm B. 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.
