Key Responsibilities :
Production & Operations Management :
Manage end-to-end
upstream processes
including
chemical reactions ,
crystallization ,
solvent recovery , and
work-up operations .
Plan and execute daily production activities to meet
output, quality, and yield
targets.
Monitor
critical process parameters (CPPs)
and ensure adherence to process design and safety.
Compliance & Documentation :
Ensure
GMP compliance , and adherence to
regulatory
and
safety guidelines
(USFDA, EDQM, TGA, WHO).
Review and approve
Batch Manufacturing Records (BMRs) ,
SOPs ,
Deviation Reports , and
Change Controls
related to upstream activities.
Prepare and support
regulatory audits ,
customer audits , and
internal inspections .
People & Resource Management :
Lead and develop a team of
shift engineers, supervisors, and operators .
Schedule manpower, oversee training and ensure adherence to
SOPs and safety practices .
Foster a culture of
accountability ,
teamwork , and
continuous improvement .
Process & Quality Improvement :
Collaborate with
R&D, Technology Transfer, and QA / QC
teams to ensure smooth
tech transfer
and
scale-up
of new products.
Drive
process optimization
to improve
yield, reduce cycle time , and
minimize solvent loss .
Lead
investigation of deviations, process failures , and implement
corrective actions .
Plant & Equipment Oversight :
Oversee the operation and maintenance of key upstream equipment :
Reactors (GLR / SSR), condensers, scrubbers, distillation units, receivers , etc.
Coordinate with the Engineering team for
preventive maintenance
and
equipment validation .
Inventory & Cost Control :
Monitor raw material consumption, solvent usage, and utility consumption.
Drive
cost-reduction initiatives
without compromising quality or compliance.
Key Skills and Competencies :
Deep understanding of
chemical reaction engineering
and
process safety .
Expertise in
hazardous reaction handling , including exothermic and pressure reactions.
Sound knowledge of
GMP ,
cGMP ,
ICH , and
regulatory requirements .
Strong leadership, team management, and problem-solving abilities.
Proficiency in production software (e.g., SAP, DCS, MES) is an added advantage.
Educational Qualifications :
B.E. / B.Tech
in
Chemical Engineering
or equivalent OR
M.Sc. in Chemistry / Organic Chemistry / Industrial Chemistry
Experience Required :
15+ years of progressive experience in
API manufacturing , with significant expertise in
upstream operations
including
reaction handling ,
crystallization , and
phase separation .
Deputy General Manager • India