AMDM Packing QMS

Hyderabad - India

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Key Responsibilities

1. Quality Management System

Manage and maintain QMS elements specific to packing operations (SOPs change control deviation management CAPA risk assessments).
Ensure timely review and approval of packing batch records logbooks and related GMP documentation.
Lead internal audits and support external audits (regulatory customer and certification bodies).
Ensure continuous compliance with local and international standards (USFDA EMA MHRA WHO PIC/S etc.).

2. Packaging Process Oversight

Oversee packaging line readiness including line clearance reconciliation and compliance checks.
Monitor adherence to packaging procedures for tablets capsules sachets and blister packs.
Approve and ensure compliance for printed packaging materials (labels cartons inserts foils).
Review and approve artwork ensuring accuracy and regulatory compliance.

3. Deviation CAPA & Change Control

Lead investigation of quality incidents related to packaging (mix-ups reconciliation failures defects).
Implement robust CAPA with effective root-cause analysis .
Manage change control for packaging process improvements material changes or equipment changes.

4. Documentation & Compliance

Maintain accurate and complete GMP documentation in alignment with data integrity principles .
Ensure timely execution of controlled documents SOP revisions and training compliance.
Enforce good documentation practices (GDP) across packing teams.

5. Training & Team Development

Conduct GMP GDP and quality-system training for packing personnel.
Build awareness of regulatory expectations and quality risk management.
mentor QA officers line QA executives and packing supervisors.

6. Continuous Improvement

Drive initiatives to reduce defects mix-ups deviations and improve packaging efficiency.
Implement Lean Six Sigma or similar tools for process optimization.
Coordinate qualification/validation of packaging equipment and supporting systems.

Key Responsibilities1. Quality Management SystemManage and maintain QMS elements specific to packing operations (SOPs change control deviation management CAPA risk assessments).Ensure timely review and approval of packing batch records logbooks and related GMP documentation.Lead internal audits and ...