rubiconresearchlimited
Senior Officer
Job description
Purpose To supervise and execute pharmaceutical formulation manufacturing operations such as granulation, compression, coating, capsule filling etc. While ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements.
Position / Job Title Senior officer - Manufacturing
Department Production/Manufacturing
Reporting To Asst. Manager/Manager/Sr. Manager
Location Indore
Years of Experience 4 -7 years' experience in manufacturing in a pharmaceutical formulation company.
Dosage Form Solid & Semi solid
Job Responsibilities / Deliverables
- Production Operations Execute and supervise manufacturing activities for tablets, capsules, semi solids depending on plant operations. Ensure production is carried out according tBatch Manufacturing Records (BMR) and Standard Operating Procedures (SOPs). Achieve daily and monthly production targets.
- GMP Compliance Ensure compliance with Good Manufacturing Practices (GMP) as per guidelines from organizations like the World Health Organization, US Food and Drug Administration, and European Medicines Agency. Maintain proper cleanroom discipline and hygiene standards.
- Equipment Operation & Maintenance Operate and monitor manufacturing equipment such as: Granulators Blenders Tablet compression machines Capsule filling machines Coating machines Coordinate with engineering for preventive maintenance and breakdown handling.
- Documentation Ensure accurate recording of Batch Manufacturing Records (BMR). Maintain Good Documentation Practices (GDP). Report and document deviations, incidents, and change controls.
- Manpower Management Supervise operators and technicians on the production floor. Allocate manpower for different manufacturing stages. Provide training on SOPs and GMP practices.
- Quality Coordination Coordinate with Quality Assurance (QA) and Quality Control (QC) for: Line clearance In-process checks Batch release activities
- Safety & Compliance Follow EHS (Environment, Health, and Safety) policies. Ensure safe handling of raw materials and equipment.
Qualifications: B. Pharm / M. Pharm
Additional notes Required Skills Strong knowledge of GMP and GDP Knowledge of tablet, capsule, semi solid manufacturing processes Production planning and troubleshooting Team supervision and coordination Audit readiness
Key Performance Indicators (KPIs) Production target achievement Compliance with GMP and SOPs Batch rejection rate Documentation accuracy Audit observations


