Job Title: Technician Capsule Filling (ACG PAM SA9)
Department: Production Solid Oral Dosage
Company: Ipca Laboratories Ltd.
Experience: 2-6 years
Location: [Dehradun.]
Role Objective
To operate, monitor, and maintain the ACG PAM SA9 capsule filling machine and associated equipment in the capsule filling section, ensuring safe, compliant, and efficient manufacturing of capsules as per cGMP and Ipca quality standards.
Key Responsibilities
1. Machine Operation & Production
- Independently operate ACG PAM SA9 (and related capsule filling equipment) as per approved SOPs and batch manufacturing records (BMR).
- Perform line clearance checks with Production/QA before start-up and product changeover.
- Set and adjust machine parameters (speed, vacuum, dosing disc, tamping pins, fill weight, locking, sorting, polishing, metal detection, etc.) to meet target output and quality.
- Ensure continuous supply and correct loading of empty capsules, blends/pellets, and prints over batch details as applicable.
- Monitor capsule filling operation for weight variation, empties, damaged capsules, loose caps, and other in-process defects and take corrective actions.
- Achieve planned production targets while minimizing machine downtime and material losses.
2. Setup, Changeover & Cleaning
- Carry out machine setup, format change/part changeover for different capsule sizes and products.
- Perform batch-to-batch and product-to-product changeover as per line clearance and cleaning SOPs.
- Execute disassembly, cleaning, and re-assembly of SA9 and associated equipment (hopper, dosing device, vacuum system, chute, polishing, metal detector, conveyors) in accordance with cGMP.
- Ensure status labeling (To Be Cleaned / Cleaned / Under Maintenance / Under Process) is correctly displayed on equipment and area.
3. InProcess Quality & Documentation
- Conduct and record inprocess checks:
- Capsule weight, appearance, locking status
- Output/yield, rejection rate
- Line clearance, sieve integrity, metal detector challenge tests (as applicable)
- Document all activities in BMR/BPR, log books, cleaning records, and online entries with legible, error-free data.
- Immediately report any deviations, incidents, or OOS/OOT results to the production officer/supervisor and assist in investigations.
- Comply with 21 CFR Part 210/211, Schedule M, and company quality systems.
4. Machine Maintenance & Troubleshooting
- Perform routine preventive maintenance and basic mechanical adjustments on SA9 capsule filling machine (alignment, lubrication, replacement of minor parts, filter cleaning, etc.).
- Identify and rectify minor mechanical, electrical, and pneumatic issues in coordination with Engineering.
- Escalate recurring or critical breakdowns promptly and support Engineering during breakdown analysis and resolution.
- Maintain good condition and accountability of change parts, tools, and spares.
5. cGMP, Safety & Compliance
- Follow all cGMP, GDP, EHS, and data integrity (ALCOA+) requirements in the production area.
- Use prescribed PPE and ensure safe operation of moving parts, compressed air, vacuum, and electrical systems.
- Participate in audits (internal, regulatory, and customer) and support implementation of CAPA in the capsule filling section.
- Maintain cleanliness and hygiene of machine, area, and personnel in accordance with SOPs and housekeeping standards (5S).
6. Training & Continuous Improvement
- Undergo and maintain qualification on SA9 and other assigned equipment through periodic training and assessments.
- Provide on-the-job training to new operators/trainees on machine operation and cGMP practices as directed.
- Actively participate in process improvement, yield improvement, and costsaving initiatives (Kaizen, Lean, etc.).
Qualifications & Experience
- Education:
- ITI / Diploma in Mechanical / Electrical / Mechatronics / Pharmacy OR
- B.Sc. / B.Pharm with relevant technical aptitude.
- Experience:
- 26 years’ hands-on experience as Operator/Technician on automatic capsule filling machines in a regulated pharmaceutical manufacturing unit.
- Mandatory exposure to ACG PAM SA9 or similar ACG / Bosch / Zanasi / IMA capsule filling machines.
Technical & Behavioral Competencies
Technical:
- Strong operating knowledge of ACG PAM SA9 capsule filling machine.
- Understanding of granulation and capsule-fill material characteristics (powders, pellets, granules).
- Familiarity with in-process controls, line clearance, and basic quality concepts.
- Ability to read and follow BMR, SOPs, logbooks, and basic maintenance instructions.
- Basic troubleshooting skills – jamming, misalignment, weight variation, vacuum and sensors.
Behavioral:
- Attention to detail and strong sense of quality and compliance.
- Discipline in documentation and adherence to procedures.
- Ability to work in rotating shifts and in a cleanroom environment.
- Good communication and teamwork with Production, QA, QC, and Engineering teams.
Reporting Structure
- Reports to: Production Officer / Executive – Capsule Filling
- Coordinates with: QA, QC, Engineering, Warehouse, EHS