Role Purpose
To manufacture dermatology products such as creams, ointments, gels, lotions, and topical solutions by operating production equipment, following approved Batch Manufacturing Records (BMRs), complying with cGMP requirements, and ensuring safety, quality, productivity, and regulatory compliance during manufacturing operations.
Key Responsibilities
Manufacturing Operations
- Perform dispensing, sifting, mixing, homogenization, emulsification, and manufacturing activities as per approved BMRs and SOPs.
- Operate manufacturing equipment such as mixers, homogenizers, planetary mixers, manufacturing vessels, transfer pumps, and storage tanks.
- Execute batch manufacturing activities within scheduled timelines.
- Monitor and control process parameters such as temperature, mixing speed, pressure, vacuum, and processing time.
- Carry out batch charging and material addition activities as per manufacturing instructions.
- Perform product transfers between manufacturing vessels and holding tanks.
- Support scale-up and technology transfer batches when required.
Equipment Operation & Maintenance
- Perform equipment preparation, assembly, dismantling, and cleaning activities.
- Conduct pre-operation checks and ensure equipment is fit for use before manufacturing.
- Record equipment usage in logbooks.
- Identify equipment abnormalities and report them to supervisors and engineering teams.
- Support preventive maintenance and equipment qualification activities.
GMP & Documentation
- Complete manufacturing records accurately and contemporaneously.
- Maintain BMRs, equipment logbooks, cleaning records, and area checklists.
- Follow Good Documentation Practices (GDP) at all times.
- Report deviations, incidents, and non-conformances immediately.
- Participate in investigations and CAPA implementation activities.
Quality Compliance
- Ensure adherence to current Good Manufacturing Practices (cGMP).
- Follow approved SOPs, specifications, and manufacturing procedures.
- Perform line clearance verification before and after batch activities.
- Ensure no mix-ups, contamination, or cross-contamination occur during production.
- Support QA during in-process checks and audits.
- Maintain batch traceability throughout manufacturing operations.
Cleaning & Hygiene
- Perform cleaning and sanitization of manufacturing equipment and production areas.
- Follow cleaning validation requirements and cleaning procedures.
- Ensure manufacturing areas are maintained in a clean and inspection-ready condition.
- Dispose of waste materials as per approved procedures.
Safety, Health & Environment
- Follow EHS policies and safe work practices.
- Use required PPE during manufacturing activities.
- Report unsafe conditions, near misses, and safety incidents.
- Participate in safety observations, risk assessments, and emergency response activities.
- Handle chemicals, active ingredients, and cleaning agents safely.
Productivity & Continuous Improvement
- Minimize process losses and material wastage.
- Support Lean, Operational Excellence, and Continuous Improvement initiatives.
- Participate in Kaizen, 5S, and productivity improvement projects.
- Contribute ideas to improve process efficiency, quality, and safety.
Audit & Inspection Readiness
- Maintain production areas in a state of audit readiness.
- Support internal, customer, and regulatory audits.
- Demonstrate process and documentation knowledge during inspections.
- Ensure compliance with USFDA, MHRA, EU GMP, WHO GMP, and other applicable regulatory requirements.
Qualification Requirements
Educational Qualification
Essential
- B.Sc,M.Sc, Diploma - Mechanical Engineering, or related discipline.
Experience
6–10 Year
