Executive/Assistant Packing
Company
NMS Consultant
Location
Mumbai, Maharashtra (+1 other)
Posted
2 days ago
Via
via Talent.com
Apply On
Job Description
Job Purpose
Responsible for overseeing the end-to-end secondary packaging operations, ensuring that all productsincluding vials and Pre-Filled Syringes (PFS)are labeled, cartoned, and coded in strict compliance with cGMP, serialization standards, and internal Quality Assurance protocols.
Key Responsibilities
1. Operational Oversight & Equipment Management
- Supervise high-speed Vial and PFS labeling lines, ensuring precision in label application and plunger rod assembly. - Manage Carton Coding operations, ensuring 102% accuracy in 2D DataMatrix, GTIN, and serialization data. - Troubleshoot and optimize specialized packaging machinery to minimize downtime and reduce rejects.
2. Visual Inspection & Quality Control
- Lead the Visual Inspection (VI) process, ensuring both Manual and Automated Visual Inspection (AVI) systems effectively identify particulate matter, container integrity issues, and fill-volume defects. - Enforce rigorous standards for "AQL" (Acceptable Quality Level) sampling during the packaging cycle.
3. Batch Execution & Documentation
- Execute and review Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) with 100% accuracy. - Perform strict Line Clearance procedures between batches to prevent cross-contamination or mix-ups. - Manage Material Reconciliation (labels, cartons, leaflets) and investigate any deviations between theoretical and actual yields.
4. Compliance & Data Integrity
- Ensure all documentation adheres to ALCOA+ principles and global regulatory standards (USFDA/MHRA/EU-GMP). - Facilitate internal and external audits by maintaining up-to-date logbooks and training records for the packaging team.
Candidate Profile
- Education: B.Pharm / M.Pharm / M.Sc or Diploma in Packaging Technology. - Experience: 5-11 years of experience in pharmaceutical secondary packaging, specifically with injectables or complex biologics. - Technical Skills: - Hands-on experience with Vial/PFS labeling machines and serialization software. - Strong understanding of Visual Inspection standards for parenteral products. - Proficiency in handling Electronic Batch Records (eBR) or MES. - Soft Skills: High attention to detail, strong team management capabilities, and the ability to work under tight production deadlines
Pls call on 9589659889 if interested
Responsible for overseeing the end-to-end secondary packaging operations, ensuring that all productsincluding vials and Pre-Filled Syringes (PFS)are labeled, cartoned, and coded in strict compliance with cGMP, serialization standards, and internal Quality Assurance protocols.
Key Responsibilities
1. Operational Oversight & Equipment Management
- Supervise high-speed Vial and PFS labeling lines, ensuring precision in label application and plunger rod assembly. - Manage Carton Coding operations, ensuring 102% accuracy in 2D DataMatrix, GTIN, and serialization data. - Troubleshoot and optimize specialized packaging machinery to minimize downtime and reduce rejects.
2. Visual Inspection & Quality Control
- Lead the Visual Inspection (VI) process, ensuring both Manual and Automated Visual Inspection (AVI) systems effectively identify particulate matter, container integrity issues, and fill-volume defects. - Enforce rigorous standards for "AQL" (Acceptable Quality Level) sampling during the packaging cycle.
3. Batch Execution & Documentation
- Execute and review Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) with 100% accuracy. - Perform strict Line Clearance procedures between batches to prevent cross-contamination or mix-ups. - Manage Material Reconciliation (labels, cartons, leaflets) and investigate any deviations between theoretical and actual yields.
4. Compliance & Data Integrity
- Ensure all documentation adheres to ALCOA+ principles and global regulatory standards (USFDA/MHRA/EU-GMP). - Facilitate internal and external audits by maintaining up-to-date logbooks and training records for the packaging team.
Candidate Profile
- Education: B.Pharm / M.Pharm / M.Sc or Diploma in Packaging Technology. - Experience: 5-11 years of experience in pharmaceutical secondary packaging, specifically with injectables or complex biologics. - Technical Skills: - Hands-on experience with Vial/PFS labeling machines and serialization software. - Strong understanding of Visual Inspection standards for parenteral products. - Proficiency in handling Electronic Batch Records (eBR) or MES. - Soft Skills: High attention to detail, strong team management capabilities, and the ability to work under tight production deadlines
Pls call on 9589659889 if interested
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