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:
Experience:
Specialized Knowledge: Licenses:
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Amneal India is a pharmaceutical company focused on developing, manufacturing, and marketing high-quality generic and specialty pharmaceutical products.