Indchemie Health Specialities Pvt. Ltd.
Website:
indchemie.in
Job details:
Job Description – IPQA Chemist
Position: IPQA Chemist / IPQA Officer
Department: Quality Assurance – In-Process Quality Assurance (IPQA)
Industry: Pharmaceutical Manufacturing
Reporting To: IPQA Executive / QA Manager
Job Objective
To ensure that manufacturing and packaging activities are carried out in compliance with GMP, approved SOPs, BMR/BPR, specifications, and regulatory requirements, and to perform effective in-process monitoring and documentation throughout the manufacturing process.
Key Responsibilities
1. In-Process Monitoring
Perform routine IPQA checks during manufacturing and packaging operations.
Verify critical process parameters (CPPs) and critical quality attributes (CQAs), wherever applicable.
Monitor environmental and operational conditions as per approved procedures.
Check compliance of production activities with approved BMR/BPR and SOPs.
2. Line Clearance
Perform and document line clearance before commencement of manufacturing and packaging activities.
Verify removal of previous product, batch materials, labels, documents, and other remnants.
Ensure equipment and area cleanliness before starting operations.
3. Sampling & In-Process Testing
Collect in-process samples according to approved sampling plans.
Perform or coordinate in-process tests such as:
Appearance
Weight variation
pH
Hardness
Thickness
Friability
Disintegration
Fill volume
Moisture, where applicable
Ensure samples are properly identified, recorded, and transferred to QC where required.
4. Batch Documentation
Review manufacturing and packaging records during operations.
Verify entries for completeness, accuracy, legibility, and compliance with Good Documentation Practices (GDP).
Ensure real-time recording of process activities and observations.
Identify and report discrepancies, omissions, and documentation errors.
5. Deviation & Non-Conformance
Identify process deviations, incidents, and non-conformances.
Immediately report critical observations to the QA supervisor/manager.
Assist in deviation investigation, root cause analysis (RCA), CAPA, and impact assessment.
6. Equipment & Area Verification
Verify equipment status labels, calibration status, cleaning status, and identification.
Ensure manufacturing areas comply with approved cleanliness and operational requirements.
Monitor compliance with gowning and personnel practices.
7. Material & Dispensing Verification
Verify dispensing of raw materials and packaging materials against approved documents.
Check material name, batch/lot number, quantity, status labels, and traceability.
Ensure correct material is used at each manufacturing stage.
8. Packaging Operations
Perform IPQA checks during primary and secondary packaging.
Verify printed packaging materials, coding details, batch number, manufacturing/expiry dates, and other statutory information.
Perform periodic checks for packing quantity, coding, sealing, labeling, and reconciliation.
9. GMP Compliance
Ensure adherence to WHO-GMP / Schedule M / applicable regulatory requirements.
Monitor personnel practices, hygiene, housekeeping, and GMP compliance on the shop floor.
Report GMP observations and support timely corrective actions.
10. Audit & Inspection Support
Support internal audits, customer audits, and regulatory inspections.
Maintain IPQA records and provide required documents during audits.
Assist in implementation and monitoring of CAPA arising from audits.
Required Skills
Good knowledge of IPQA, GMP, GDP, SOPs, BMR/BPR and pharmaceutical manufacturing processes.
Understanding of pharmaceutical dosage forms and manufacturing operations.
Knowledge of deviation, CAPA, change control, OOS/OOT and risk management.
Good documentation and communication skills.
Ability to identify GMP deficiencies and take appropriate action.
Basic knowledge of Data Integrity principles (ALCOA+).
Ability to work in shifts and coordinate effectively with Production, QC and Engineering departments.
Qualification & Experience
Qualification: B.Sc./M.Sc. Chemistry, B.Pharm/M.Pharm, or equivalent pharmaceutical/chemical qualification.
Experience: Typically 1–5 years of experience in IPQA/Quality Assurance in a pharmaceutical manufacturing facility, depending on the position level.
Key Performance Indicators (KPIs)
Timely completion of IPQA checks and line clearances.
Accuracy and completeness of batch documentation.
Compliance with GMP and SOP requirements.
Timely identification and escalation of deviations.
Reduction in recurring GMP/process observations.
Effective support for audits and regulatory inspections.
Compliance with documentation and data-integrity requirements.
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