1.0

Release of Technology Transfer Dossier (TTD) to the CMO Sites from R&D;:

Responsible for TTD release from R&D; to Manufacturing Site.

Review and approval of internal and external technology transfer to CMO sites

Supporting the execution of validation batches and commercial batches at manufacturing site as per the agreed timeline.

Responsible for evaluating and implementing the ICH and QbD concepts at Tech Transfer phase including QTPP, CQA, CPP and CMA.

Review and authorization of technical packages and TTD, as required

Review and approval of gap assessments

Review and approval of process validation design and reports

Support in case of any RFI from regulatory agency

Supporting the dossier submission from technical aspects and post variation filings, as required.

2.0

Trend Analysis and Continuous Improvement:

Analyze quality data, identify trends, and drive continuous improvement initiatives to enhance quality and compliance.

3.0

Collaboration:

Work with other departments, such as Technology Transfer, Research and Development, Manufacturing, Quality Control, and Regulatory Affairs, to ensure a seamless integration of quality throughout the product lifecycle.

4.0

Quality Operations Oversight:

Manage all Quality Assurance and Quality Control activities, ensuring seamless and compliant execution.

Ensure shop floor/manufacturing activities are performed per written procedures and cGMP guidelines.

5.0

Quality Management System (QMS):

Implement and maintain an effective QMS aligned with regulatory and corporate standards.

Monitor QMS performance and lead continual improvement initiatives.

6.0





Document and SOP Management:

- Review and approve Standard Operating Procedures for QA, QC, and other departments.
- Approve Site Master File, Validation Master Plan, protocols, reports, and Annual Product Quality Review (APQR).

7.0

Laboratory and Testing Oversight:

- Ensure all product and material testing is conducted per approved specifications.
- Maintain turnaround time (TAT) for both chemical and microbiological testing sections.

8.0

Deviation and CAPA Management:

- Ensure timely initiation, investigation, documentation, review, and approval of deviations, OOS, OOT, and market complaints.
- Approve CAPAs, ensure proper implementation, and verify effectiveness as per commitments.

9.0

Vendor and Material Qualification:

- Lead the vendor qualification process, ensuring all suppliers and contractors meet quality requirements.

10.0

Training and Personnel Oversight:

- Impart training to QA/QC and other concerned personnel.
- Approve job responsibilities for all personnel within the QA and QC departments.

11.0

Audit and Compliance Activities:

- Participate in customer audits and regulatory inspections.
- Ensure timely self-inspections are performed and compliance is maintained.
- Provide documentation and responses to regulatory bodies in a timely manner.

12.0

Facility and Equipment Qualification:

- Approve equipment and facility qualification protocols and maintenance schedules.

13.0

Risk Management:

- Lead the implementation of risk management practices across operations to proactively identify and mitigate potential quality risks.Role & responsibilities

📌 Manager & above - QA (Bengaluru)
🏢 Lyrus Life Science
📍 Bengaluru