Experience: 4-8 years in pharmaceutical packaging development
Responsibilities:
Packaging Solutions & Development
- Design, evaluate, and implement packaging materials and solutions suitable for various dosage forms (solid oral, blister, strip, etc.).
- Conduct line trials and develop packaging material specifications.
Validation & Qualification
- Plan and execute packaging equipment validation, qualification, Factory Acceptance Test (FAT), and Site Acceptance Test (SAT) projects.
- Prepare and review protocols/reports for packaging equipment qualification and validation activities.
Quality Management System (QMS)
- Ensure compliance with QMS requirements, including change controls, deviations, CAPA, and documentation as per GMP standards.
- Collaborate with cross-functional teams to ensure packaging processes meet regulatory and quality standards.
Technical Knowledge of Packaging Equipment
- Operate and support packaging operations for Auto Cartonator (ACG PAM PAC CP 150), Blister Packing Machines, and Strip Packing Machines.
- Provide troubleshooting support for packaging equipment during trials and routine production.
Vendor Sourcing & Management
- Identify, evaluate, and qualify vendors for packaging materials and machinery.
- Coordinate with suppliers for timely availability, cost optimization, and quality compliance of packaging components.
Lifecycle Management
- Manage packaging changes throughout the product lifecycle (new product introduction, cost improvement, sustainability initiatives, and regulatory updates).
- Maintain packaging documentation, specifications, and master data for lifecycle tracking.
Requirements:
Strong understanding of pharmaceutical packaging technologies and materials.
Hands-on experience with packaging machines (Auto Cartonator, Blister, Strip packing).
Knowledge of QMS, regulatory compliance, and GMP practices.
Project management skills for FAT/SAT and equipment validation.
Vendor management and negotiation skills.
Analytical and problem-solving abilities.
Good communication and documentation skills.
Qualification & Experience:
Diploma in packaging development or equivalent.
4-8 years of experience in pharmaceutical packaging development.
Exposure to packaging machinery (ACG PAM PAC CP 150, blister & strip machines) is desirable.
Technical Aspects of Packing Coordination (Pharmaceuticals):
1.
Artwork Management
- Manage artwork creation, revision, and approval as per regulatory guidelines (EMA, WHO, CDSCO).
- Ensure compliance of carton, foil, and label information with the approved dossier (MA File).
- Control master packing records (MPR) and batch packing records (BPR).
2.
Packing Material Specifications
- Define and maintain specifications for primary, secondary, and tertiary packaging:
-
Primary:
Blister
Job Type: Full-time
Pay: ₹600,000.00 - ₹1,000,000.00 per year
Work Location: In person
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