Title:  Senior Executive - Packing QMS

Position Summary

The Executive – Packing QMS is responsible for implementing, maintaining, and monitoring Quality Management System (QMS) activities related to OSD packing operations, ensuring compliance with USFDA, cGMP, and data integrity requirements. The role supports documentation control, deviation management, change control, and audit readiness within the packing function.

Key Responsibilities

Packing QMS & GMP Compliance

• Ensure implementation and adherence to QMS requirements across primary and secondary packing operations.
• Monitor compliance with cGMP, USFDA, WHO, and internal quality standards in packing areas.
• Ensure adherence to data integrity (ALCOA+) principles in all packing‑related documentation.

Documentation Management

• Review and control Batch Packing Records (BPRs), logbooks, checklists, and line clearance records.
• Ensure timely review, correction, and closure of packing documentation.
• Support preparation, revision, and implementation of packing SOPs, formats, and policies.

Deviation, CAPA & Change Control

• Initiate, investigate, and track deviations, incidents, and non‑conformances related to packing activities.
• Support root cause analysis (RCA) and implement effective CAPA.
• Handle change control processes related to packing equipment, processes, materials, and documents.
• Monitor effectiveness checks and timely closure of quality events.

Audit & Inspection Support

• Support USFDA, MHRA, WHO, customer, and internal audits related to packing QMS.
• Prepare packing QMS documentation and present data to auditors.
• Assist in preparation and closure of audit observations within timelines.

Training & Compliance Monitoring

• Support GMP and QMS training programs for packing personnel.
• Monitor compliance to SOPs, line clearance, and gowning practices on shop floor.
• Participate in periodic Gemba walks and compliance checks for packing areas.

Coordination & Cross‑Functional Support

• Coordinate with Packing, Production, QC, Engineering, and Warehouse teams for quality compliance.
• Support new product introductions, artwork changes, and scale‑up from a QMS perspective.
• Assist QA during batch disposition and packing batch release activities.

Qualifications & Experience

Education

• Bachelor’s degree in Pharmacy
  (B.Pharm / M.Pharm preferred)

Experience

• 6–9 years of experience in Packing QMS 
• Mandatory exposure to USFDA‑approved OSD manufacturing facility

Technical & Regulatory Knowledge

• Strong understanding of USFDA, cGMP, ICH, WHO guidelines
• Hands‑on experience in BPR review, deviation, CAPA, and change control
• Knowledge of OSD packing operations (blister, bottle, strip, secondary packing)
• Familiar with data integrity, GDP, risk assessment tools

Key Skills & Competencies

• Strong documentation and analytical skills
• Good communication and coordination abilities
• Audit‑ready and compliance‑driven mindset
• Ability to work in shifts and handle shop‑floor QMS activities

Preferred

• Direct involvement in USFDA audits related to packing
• Experience in artwork control and packing configuration management