Assistant Manager I, Quality Compliance

Submission to regulatory authorities associated with various regulatory requirements, authoring / or coordinating RA activities for new registrations / licenses, post approval changes, renewals, GMP Certification applications, annual reports and line extensions to meet requirements.

Coordinating and contributing to responses to Agency queries and performing quality review of regulatory submissions.

Coordination for cGMP Training activity including training of identified people.

Review and approval of Artwork / Labelling.

Understand the requirements for implementation

Perform the Gap analysis to find out the gaps in existing system

Prepare a compliance plan for closure of gaps ( if any)

Execution of compliance plans

Review of completion for compliance activity

Review of protocols for qualification and validation of facility/ equipment / product / process

Review and certification of validation reports after execution of validation of facility /equipment / product / process

To develop training modules and organize training in GMP

Develop and execute the overall training program in coordination with all concerned departments

Preparation, review and approval of site master file

Preparation, review and approval of high quality documents as per ICH / regulatory requirements for submission to Health Authorities / Global Regulatory Affairs / Business Partners

Coordinating with various stakeholders for establishing quality technical agreements

Develop, implement, and maintain a robust supplier quality assurance system aligned with cGMP and regulatory requirements (e.g., USFDA, EMA, WHO).

Lead supplier qualification, requalification, and performance monitoring programs.

Conduct risk-based assessments and ensure supplier categorization based on product and service criticality.

Plan, conduct, and follow up on supplier audits (on-site and remote) for API, excipient, packaging, and service providers.

Evaluate audit findings, identify gaps, and oversee closure of CAPAs with suppliers.

Maintain audit schedules, records, and ensure timely reporting.

Maintenance of Approved Supplier List / GMP documents / Supplier files

To Act as a regulatory interface with Global Regulatory Affairs or with Affiliate Regulatory Affairs for site

To provide results of regulatory indicators applicable to site

To Implement appropriate company tools to manage identified activities

Contributes to site GMP inspections and audit

Review and sign-off documents like SOPs or technical reports

To perform the responsibilities as assigned by line Manager