1. Core QMS Element Management & Documentation

- Deviation Management: Coordinate and review tablet/capsule manufacturing and packaging line deviations, ensuring rigorous root-cause analysis (e.g., Fishbone, 5-Why).

- CAPA (Corrective and Preventive Actions): Log, track, and verify the implementation and effectiveness of CAPAs to prevent issues like tablet capping, weight variation, or capsule splitting from recurring.

- Change Control: Author and process change controls regarding manufacturing equipment (e.g., compression machines, encapsulation lines, blister packers) or batch size scale-ups.

- Investigation Handling: Execute detailed quality investigations for Market Complaints, OOS (Out of Specification), and OOT (Out of Trend) laboratory results.

1. Batch Record & Technical Review (Tablets/Capsules)

- BMR & BPR Review: Thoroughly review executed Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) for completeness, yield reconciliations, and compliance with data integrity principles (ALCOA+) before releasing product batches.

- Master Documentation Support: Help in drafting, updating, and issuing master production formulas, Standard Operating Procedures (SOPs), and logbooks.





- APQR (Annual Product Quality Review): Compile and analyze trending data for tablet and capsule parameters (such as dissolution curves, hardness, friability, and assay values) to prepare annual reports.

1. Validation, Calibration, & Lifecycle Tracking

- Validation Protocols: Review and archive protocols and execution data for Process Validation, Cleaning Validation (ensuring no cross-contamination between different drug molecules), and Equipment Qualifications (IQ/OQ/PQ).

- Calibration Schedules: Track and maintain records for the calibration and preventive maintenance of tablet/capsule equipment and QC laboratory testing instruments. [1, 2]

- Technology Transfer Documents: Review technical transfer and validation packages coming from formulation research & development (FR&D;).

Pay: ₹30,000.00 - ₹40,000.00 per month

Perks

- Flexible schedule

- Food provided

- Health insurance

- Internet reimbursement

- Leave encashment

- Life insurance

- Paid sick time

- Provident Fund

Education

- Bachelor's (Required)

Experience

- QMS Documantation: 5 years (Required)

Work Location: In person

📌 Sr. Executive QMS Documentation ( Tablate & Capsul) (Haridwar)
🏢 ASPIRIT VISION SOLUTION
📍 Haridwar