reactors, centrifuges, dryers, distillation columns, scrubbers, filtration, vacuum systems
.
Ensure preventive maintenance, calibration, and smooth operation of all equipment.
Troubleshoot production issues, process deviations, or equipment failures promptly.
3. Documentation & GMP Compliance
Ensure
accurate documentation in BMR, MFR, Logbooks, SOPs
.
Maintain compliance with
GMP, cGMP, ICH Q7
standards.
Oversee
cleaning validation, equipment qualification
, and production records.
Ensure
data integrity (ALCOA+)
across all documentation.
4. Export & Merchant Export Coordination
Coordinate with
Export / Accounts team
for batch dispatches.
Ensure
Merchant Exporter documentation
(CT1, LUT, COA, SDS, Packing List).
Support export account handling for domestic and international shipments.
5. ERP / CRM Pharma Software Management
Maintain
production planning, batch tracking, inventory management
using ERP/CRM software.
Generate reports for
production performance, material usage, and batch yield
.
Monitor
production KPIs and MIS reports
for management review.
6. Team Management & Leadership
Supervise
Production Chemists, Operators, and Helpers
across shifts.
Conduct
training on GMP, safety, SOPs, and process improvements
.
Build a culture of accountability, discipline, and safety in the plant.
7. Safety & Regulatory Compliance
Ensure
EHS compliance
in chemical handling, reaction safety, and plant operations.
Conduct
risk assessments
, monitor near misses, and implement preventive actions.
Ensure compliance with
domestic & international regulatory standards
.
8. Business Development Support
Coordinate with Sales & Marketing team for
new product manufacturing and export-ready batches
.
Support technical queries, scale-up, and feasibility studies for new APIs.
Contribute to
cost optimization and process improvement
for export and domestic customers.
Required SkillsTechnical Skills
Mandatory:
10-15+ years in
Pharma API Manufacturing Plant
(Domestic + Export).
Strong knowledge of
multi-step chemical reactions
, API production, and process scale-up.
Hands-on experience in
reactor operations, drying, filtration, distillation, vacuum systems
(Tally, SAP, BatchMaster, Spectrum ERP, etc.).
Familiarity with
export account handling and Merchant Exporter documentation
.
Soft Skills
Strong
leadership, team management, and decision-making
skills.
Excellent communication, coordination, and problem-solving abilities.
Target-driven, safety-conscious, and quality-oriented mindset.
Ability to handle pressure during critical production processes.
Experience Required
10-15+ years in Pharma API Production / Plant Operations
.
Experience in
domestic & export API production
, multi-molecule manufacturing.
Experience with
documentation, ERP/CRM, and export account coordination
.
Salary Range
?12,00,000 - ?20,00,000 per annum
(Based on experience, expertise in API manufacturing, export handling, and plant size)