27 Sep
|
VIP Pharmaceuticals
|
Baddi
27 Sep
VIP Pharmaceuticals
Baddi
Senior Production Executive Production (Tablets & Capsules)
Department: Production – Formulations
Designation: Senior Production Executive
Reporting To: Production Manager / Assistant Manager – Production
Location: Pharmaceutical Formulations Manufacturing Plant
Industry: Pharmaceutical Manufacturing – Oral Solid Dosage (Tablets & Capsules)
Job Purpose To supervise and monitor day-to-day manufacturing activities on the shop floor for granulation, compression, coating, capsule filling and packing operations, ensuring production is carried out safely, efficiently, and in accordance with cGMP, SOPs, BMR/BPR, safety requirements and applicable regulatory standards.
The position will be responsible for effective floor monitoring, manpower coordination, process compliance, documentation, equipment readiness and timely escalation of production-related issues.
Key Responsibilities
1. Shop-Floor Production Monitoring
- Monitor day-to-day manufacturing activities for:
- Dispensing/charging and granulation activities
- Drying, milling and lubrication/sifting operations
- Tablet compression
- Tablet coating
- Capsule filling
- Primary and secondary packing activities
- Ensure manufacturing activities are performed as per approved BMR/BPR, SOPs and established process parameters.
- Monitor production progress against the approved production plan and communicate deviations/delays to the Production Manager.
- Ensure proper line clearance and area readiness before commencement of activities.
- Monitor equipment status, machine settings and availability of required materials/components.
- Ensure proper identification and status labeling of materials, intermediates, bulk products and finished products.
- Monitor in-process activities and coordinate with IPQA/QC wherever required.
2. GMP & Compliance
- Ensure compliance with cGMP requirements, SOPs, safety procedures and site quality systems.
- Maintain discipline and GMP practices on the manufacturing floor.
- Ensure personnel follow proper gowning, hygiene and contamination-control practices.
- Identify and immediately report GMP observations, process abnormalities and unsafe practices.
- Support investigation of deviations, incidents, OOS/OOT-related production observations and other quality events as applicable.
- Ensure corrective and preventive actions assigned to Production are implemented within the defined timelines.
- Support internal, customer and regulatory audits by providing required production records and information.
3. Documentation
- Ensure accurate, complete and timely documentation of all manufacturing activities.
- Review manufacturing documents for completeness, correctness and compliance with approved procedures.
- Maintain and verify
- Batch Manufacturing Records (BMR)
- Batch Packing Records (BPR)
- Equipment and area logbooks
- Cleaning records
- Machine usage records
- In-process monitoring records
- Yield/reconciliation records
- Line clearance records
- Temperature/RH and other applicable records
- Ensure entries are made contemporaneously and in accordance with Good Documentation Practices (GDP).
- Review production records for missing entries, discrepancies and documentation errors and escalate appropriately.
- Ensure proper documentation and reporting of process deviations and abnormalities.
4. Manpower Management
- Supervise and allocate production operators/workers according to the production plan and operational requirements.
- Monitor manpower utilization and productivity on the shop floor.
- Ensure operators are adequately trained and follow approved SOPs and work instructions.
- Coordinate shift activities and ensure proper handover/takeover between shifts.
- Identify training requirements and communicate them to the Production Manager.
5. Equipment & Process Monitoring
- Ensure production equipment is available, clean, identified and fit for use before operation.
- Monitor machine performance and report breakdowns or abnormal equipment conditions to Engineering/Maintenance.
- Coordinate with Engineering for preventive maintenance and breakdown-related activities affecting production.
- Monitor critical process parameters and ensure they remain within approved limits.
- Escalate recurring equipment/process issues for investigation and corrective action.
6. Material & Yield Control
- Coordinate with Warehouse/Stores for timely availability of approved raw materials, packing materials and other production requirements.
- Ensure material identity, status and quantities are verified before use.
- Monitor material consumption, reconciliation and batch yields.
- Report unusual yield variations, material shortages or reconciliation discrepancies to the concerned department.
7. Coordination with Other Departments
- Coordinate closely with QA/IPQA, QC, Warehouse, Engineering/Maintenance, Planning and EHS for smooth execution of production activities.
- Ensure timely sampling, testing and release-related activities in coordination with QC/QA.
- Coordinate with QA/IPQA for line clearance, in-process checks and batch documentation review.
- Communicate production status, issues and constraints to the Production Manager.
8. Safety & Housekeeping
- Ensure safe working practices are followed by all personnel in the assigned production areas.
- Monitor proper use of PPE and compliance with EHS requirements.
- Ensure good housekeeping and cleanliness of production areas.
- Report unsafe conditions, incidents and near misses promptly.
- Ensure production areas and equipment are maintained in a clean and orderly condition.
9. Shift Reporting & MIS
- Prepare and maintain shift-wise production reports.
- Report actual production versus plan, machine utilization, downtime, rejection, yield and major production issues.
- Ensure proper shift handover covering:
- Batch status
- Equipment status
- Documentation status
- Quality issues/deviations
- Pending activities
- Material availability
- Maintenance requirements
- Provide timely updates to the Production Manager regarding critical issues and production delays.
Key Performance Areas (KPIs)
- Achievement of production plan and batch completion timelines
- Compliance with BMR/BPR and SOP requirements
- Documentation accuracy and completeness
- Reduction/prevention of documentation errors
- GMP compliance on the shop floor
- Batch yield and material reconciliation
- Equipment utilization and reduction of avoidable downtime
- Timely closure/escalation of deviations and production issues
- Manpower productivity and utilization
- Safety and housekeeping compliance
- Audit readiness and compliance
Qualification
- B.Pharm / M.Pharm preferred.
- B.Sc./M.Sc. or other relevant pharmaceutical/technical qualification may also be considered depending on organizational requirements.
Experience
- 4–8 years of relevant experience in pharmaceutical formulation manufacturing.
- Experience in tablet and capsule manufacturing is preferred.
- Hands-on exposure to granulation, compression, coating, capsule filling and packing operations is required.
- Experience in GMP documentation and shop-floor production activities is essential.
Technical & Functional Skills
- Good knowledge of pharmaceutical manufacturing processes for oral solid dosage forms.
- Working knowledge of cGMP, GDP, SOPs, BMR/BPR and batch documentation.
- Understanding of granulation, compression, coating, capsule filling and packing processes.
- Ability to identify process abnormalities and escalate issues appropriately.
- Good knowledge of line clearance, cleaning verification and material reconciliation practices.
- Good documentation and record-review skills.
- Basic knowledge of production planning, yield calculation and productivity monitoring.
- Good coordination and communication skills.
- Ability to manage production activities in a shift-based manufacturing environment.
Behavioural Competencies
- Strong shop-floor presence and ownership.
- Attention to detail.
- Valuable communication and interpersonal skills.
- Team handling and coordination ability.
- Problem-solving approach.
- Ability to work under production timelines while maintaining GMP compliance.
- Discipline and commitment to documentation accuracy.
- Ability to escalate critical issues promptly.
Working Conditions
- Primarily shop-floor based within pharmaceutical manufacturing areas.
- Willingness to work in rotational shifts, including night shifts where applicable.
- Must follow prescribed gowning, hygiene, PPE and safety requirements.
- May be required to support production activities during audits, inspections, validation activities and urgent manufacturing requirements.
Authority & Accountability The Senior Production Executive is accountable for ensuring that assigned manufacturing activities are executed as per approved procedures, GMP requirements, production schedules and quality standards, while ensuring accurate documentation and timely communication/escalation of any deviations or abnormalities.
📌 Senior Production Executive (Tablets, Capsules & Oral Liquids) (Baddi)
🏢 VIP Pharmaceuticals
📍 Baddi