1. Job Purpose
To execute and monitor pharmaceutical solid dosage manufacturing activities in accordance with approved SOPs, Batch Manufacturing Records (BMRs), GMP requirements, and safety standards, ensuring products are manufactured consistently, safely, and according to defined quality specifications and production plans.
2. Key Roles & Responsibilities
- Execute solid dosage manufacturing processes such as dispensing, sifting, granulation, blending, compression, coating, and related preparation activities as applicable.
- Follow approved SOPs, BMRs, GMP, safety, and hygiene requirements throughout production activities.
- Ensure correct identification, quantities, status, and handling of raw and packaging materials before and during processing.
- Operate and monitor production equipment according to approved procedures and equipment parameters.
- Perform and document in-process checks and process parameters as required.
- Ensure accurate and timely completion of BMRs, logbooks, checklists, and other production documentation.
- Monitor production activities to ensure compliance with approved process parameters and report any deviations or abnormalities.
- Coordinate with Quality Control, Quality Assurance, Warehouse, Engineering, and Maintenance to resolve production-related issues.
- Ensure proper cleaning, line clearance, equipment status, and area readiness before starting production activities.
- Maintain high standards of GMP, housekeeping, personal hygiene, and contamination control within production areas.
- Support investigation of deviations, non-conformities, and process-related issues and implement approved corrective actions.
- Support process improvement initiatives aimed at improving productivity, yield, quality, and operational efficiency.
- Ensure safe handling and use of pharmaceutical materials and equipment and comply with EHS requirements.
- Escalate any quality, safety, equipment, or process concerns to the responsible supervisor/manager.
- Perform other production-related duties as assigned by the Production Management.
3. Education
- Bachelor’s Degree in Pharmaceutical.
- Professional registration/licensing as required by applicable local regulations.
4. Qualifications & Requirements
- 0–3 years of relevant experience in pharmaceutical manufacturing, preferably in solid dosage production.
- Good knowledge of GMP, pharmaceutical manufacturing practices, and production documentation.
- Basic understanding of solid dosage manufacturing processes and equipment.
- Good understanding of SOPs, BMRs, deviations, and in-process controls.
- Good attention to detail and commitment to documentation accuracy.
- Ability to work effectively in a controlled production environment and follow strict procedures.
- Good communication, teamwork, and problem-solving skills.
- Ability to work under production schedules and, when required, rotational shifts.
