in pharmaceutical manufacturing. The role involves optimizing production processes, troubleshooting technical issues, and ensuring adherence to cGMP standards.
Key Responsibilities:
Process Optimization & Control:
Improve and monitor manufacturing processes to enhance productivity, efficiency, and product consistency while minimizing waste and downtime.
Technical Troubleshooting:
Investigate and resolve production issues such as deviations, yield variations, and equipment malfunctions to ensure smooth operations.
Process Validation & Documentation:
Support the preparation and execution of process validation protocols (IQ/OQ/PQ) and ensure timely documentation in line with cGMP and regulatory standards.
Compliance & GMP Adherence:
Ensure strict compliance with
GMP
,
SOPs
, and all applicable regulatory guidelines (e.g.,
FDA
,
EU-GMP
,
ICH
).
New Product Introduction (NPI):
Assist in the scale-up and technology transfer of new products from R&D or other sites to commercial production.
Cross-functional Collaboration:
Work closely with QA, QC, Engineering, R&D, and EHS teams to support operations and implement corrective and preventive actions (CAPA).
Continuous Improvement:
Participate in Lean Manufacturing and Six Sigma initiatives to identify process improvement opportunities and cost-saving measures.
Equipment Support:
Participate in equipment qualification, troubleshooting, and ongoing maintenance planning to ensure reliable operation.
Required Qualifications:
Bachelor's degree in Chemical Engineering, Pharmaceutical Engineering, or related field.
3 to 6 years of relevant experience
in a pharmaceutical manufacturing environment.
Strong knowledge of
cGMP
,
FDA
,
EU GMP
, and other regulatory frameworks.
Experience with
process validation
,
batch documentation
,
deviation handling
, and
change control systems
.
Familiarity with solid oral dosage, sterile, or API production processes (customizable per your site).
Good understanding of production equipment and cleanroom requirements.
Proficient in MS Office tools; experience with ERP/MES systems is an advantage.
Job Type: Full-time
Work Location: In person
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