POSITION SUMMARY:

The IPQA Specialist is a member of the Manufacturing Quality Assurance department at the Monroe manufacturing facility, reporting to either IPQA Supervisor/Manager . Primary responsibilities for this position are to provide quality support and oversight while production activities are underway in preparation (e.g., line clearance, material staging, label preparation, etc.) and during manufacturing, filling, packaging, validation, etc. The IPQA Specialist reviews and compiles BPR data associated with Glenmark products, participates and assists management of the visual inspection program for the sterile injectable products, provides oversight of critical Utility operations.

OVERALL JOB RESPONSIBILITIES

• Maintain quality system controls to ensure state of compliance and no critical and major market complaints to prevent costly recalls.
• Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency.
• Perform line clearance and approval for use of areas/rooms for Dispensing, Sampling, Manufacturing and Packaging.
• Obtain and analyse utility samples as needed.
• Perform Packaging label creation.
• Provide Quality support during In-Process Sampling, Validation, Cleaning Verification, activities, etc.
• Perform regularly-scheduled and as-needed Compliance walk-throughs in Production and Warehouse.
• Maintain Retain Sample storage.
• SME for visual inspection for vial and syringe products
• Perform AQL visual inspection of finished good products
• Review batch manufacturing documentation and assist Production personnel with documentation.
• Ensure compliance with Standard Operating Procedures (SOPs), Forms, Batch Production Records, Protocols, as needed.
• Operate in compliance of cGMP, 21CFR, USP, EP and ICH regulatory requirements.

KNOWLEDGE, SKILLS AND ABILITIES

Education

(degree / diploma)

• Bachelor’s degree in scientific discipline or closely related technical field of study.

Experience

• 3+ years of relevant pharmaceutical manufacturing experience
• Experience in data review function of with previous experience on the floor in Manufacturing (Dispensing, Pouching, Inspection and Packaging, etc.) and/or Quality experience.
• Quality experience is preferred.

Knowledge and Skills (Functional / Technical)

• Strong Technical writing skills.
• Knowledge of current cGMP regulations.
• Proficient in Windows, Microsoft Word, Excel.
• Good written, verbal, and communication skills.
• Good documentation skills.
• Strong organizational skills.
• Time management

Leadership / Managerial Attributes

• No direct or indirect reports/Individual Contributor.