IPQA - Officer

IPQA Officer Oral Formulation

Department: Quality Assurance (QA)
Designation: IPQA Officer / Sr.Officer Oral Formulation
Dosage Forms: Tablets, Capsules, and Oral Solid Dosage Forms
Reporting To: IPQA Manager / QA Manager

1. Job Purpose

To ensure that all manufacturing and packaging activities for oral formulations comply with approved SOPs, Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), Good Manufacturing Practices (GMP), and applicable regulatory requirements.

2. Key Responsibilities

A. Line Clearance and Manufacturing Activities

• Perform line clearance before starting manufacturing, compression, coating, capsule filling, and packaging activities.
• Verify cleanliness of equipment, area status, equipment identification, and removal of previous product and batch materials.
• Check and verify BMRs, BPRs, equipment logbooks, and relevant manufacturing documents.
• Monitor dispensing, sifting, granulation, drying, milling, blending, lubrication, compression, coating, and capsule filling operations.
• Verify product, batch number, material status, equipment status, and process parameters during manufacturing.
• Ensure adherence to approved SOPs, GMP, GDP, and safety requirements.

B. In-Process Quality Control

• Perform or verify in-process checks as per approved procedures and specifications.
• Monitor critical process parameters and critical quality attributes during manufacturing.
• Verify compression parameters such as:
• Average weight and individual tablet weight
• Thickness and diameter
• Hardness and friability, where applicable
• Disintegration, where specified
• Appearance and defects
• Monitor capsule filling parameters, including fill weight, capsule locking, appearance, and integrity.
• Verify coating parameters such as inlet/outlet temperature, spray rate, pan speed, and weight gain, as applicable.
• Ensure sampling is performed according to approved sampling plans.
• Record observations and results in the relevant documents and report deviations promptly.

C. Documentation and Compliance

• Review and verify real-time entries in BMRs, BPRs, equipment usage logs, and cleaning records.
• Ensure entries comply with Good Documentation Practices (GDP).
• Verify reconciliation of raw materials, intermediates, bulk products, and packaging materials, as applicable.
• Ensure proper status labeling and identification of materials, equipment, and products.
• Maintain traceability and data integrity in accordance with ALCOA+ principles.

D. Deviation, CAPA, and Change Control

• Report and document deviations, incidents, and process abnormalities.
• Participate in investigations related to out-of-specification (OOS) and out-of-trend (OOT) results, where applicable.
• Support root cause analysis and implementation of Corrective and Preventive Actions (CAPA).
• Monitor compliance with approved change controls and assess their impact on manufacturing operations.
• Escalate critical quality issues to the QA/IPQA Manager.

E. Cleaning and Validation

• Verify equipment and area cleaning status before use.
• Ensure compliance with approved cleaning procedures and cleaning validation requirements.
• Participate in process validation, cleaning validation, and equipment qualification activities as assigned.
• Verify execution of validation batches and adherence to approved protocols.

F. Packaging Line Activities

• Perform line clearance before primary and secondary packaging.
• Verify printed packaging materials, product details, batch number, manufacturing/expiry dates, and coding details.
• Monitor blister packing, bottle packing, strip packing, labeling, and cartoning operations, as applicable.
• Verify online coding, leak tests, vision systems, and other applicable in-process checks.
• Ensure proper reconciliation and control of printed packaging materials.
• Investigate and report packaging discrepancies and mix-up risks.

G. Audit and Regulatory Compliance

• Support internal audits, customer audits, and regulatory inspections.
• Ensure compliance with applicable GMP requirements, approved site procedures, and regulatory commitments.
• Participate in training and maintain required qualification records.
• Promote a quality-focused culture and continuous improvement.

3. Educational Qualification

• B.Pharm, M.Pharm in a relevant discipline, as per company requirements.

4. Experience

• Freshers or candidates with relevant pharmaceutical manufacturing/IPQA experience, depending on the position level.
• Experience in oral solid dosage manufacturing is preferred for experienced positions.

5. Required Skills

• Knowledge of GMP, GDP, and pharmaceutical quality systems.
• Understanding of oral solid dosage manufacturing processes.
• Knowledge of BMR/BPR review and in-process controls.
• Good documentation, communication, and investigation skills.
• Attention to detail and ability to identify and escalate quality risks.
• Familiarity with deviations, CAPA, change control, and data integrity.

6. Key Performance Indicators (KPIs)

• Timely and accurate completion of line clearance and in-process checks.
• Compliance with BMR/BPR documentation requirements.
• Timely reporting and escalation of deviations.
• Reduction in documentation errors and repeat discrepancies.
• Compliance with GMP requirements and audit observations.
• Timely completion of assigned QA activities and training.

Note: This JD should be aligned with the site's approved procedures, actual job responsibilities, and applicable GMP requirements before implementation.