04 Sep
|
Rubicon Research
|
Indore
04 Sep
Rubicon Research
Indore
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
Pithampur
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 to Batch Manufacturing Records (BMR) and Standard Operating Procedures (SOPs). Achieve daily and monthly production targets.
GMP Compliance
Ensure compliance with Positive 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 Positive 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 Education
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
📌 Senior Officer (Indore)
🏢 Rubicon Research
📍 Indore