will be responsible for overseeing and controlling all injection molding and aseptic production operations for pharmaceutical-grade components such as
Pre-Filled Syringes (PFS), Vials, and Cartridges
under
GMP and cleanroom conditions
. The role ensures adherence to regulatory and quality standards, efficient resource utilization, and continuous improvement in safety, productivity, and compliance.
Key Responsibilities:
Project Planning & Execution:
Develop production plans, allocate resources, and oversee the execution of manufacturing schedules to meet quality and delivery timelines.
Problem-Solving & Decision-Making:
Identify and resolve production issues promptly, ensure minimal downtime, and make informed decisions to maintain operational efficiency.
Cross-Functional Collaboration:
Coordinate with departments such as
, Quality Assurance, Maintenance, and Supply Chain
to ensure smooth production flow and compliance with GMP standards.
Leadership & Team Development:
Lead, train, and mentor production supervisors and operators, promoting a culture of continuous improvement, accountability, and operational excellence.
Process Improvement & Innovation:
Implement Lean, Kaizen, and 5S initiatives to optimize processes, improve yield, reduce waste, and enhance overall productivity.
Technical & Customer Coordination:
Collaborate with technical and design teams for troubleshooting and liaise with customers on product specifications to ensure satisfaction through timely delivery of high-quality products.
Manufacturing Operations:
Supervise and control production areas involved in
(PFS, Vial & Cartridge Filling, Isolator systems, VHP, and Inspection).
Documentation & Compliance:
Ensure accurate preparation and review of
SOPs, Batch Manufacturing Records (BMR), and Batch Packaging Records (BPR)
in accordance with GDP practices.
Regulatory & QMS Activities:
Manage
Media Fill trials
,
Change Control
,
Deviation
,
CAPA
, and
Investigation
activities as per Quality Management System (QMS) standards.
Manpower Management:
Allocate daily work schedules, monitor operator performance, and ensure adequate staffing for all shifts to meet production goals.
Qualification & Experience:
Education:
B.Pharm / M.Pharm / M.Sc. (Pharmaceuticals / Chemistry / Biotechnology or related field)
Experience:
Minimum [8-15] years of experience in
Injection Molding and Aseptic Manufacturing
within a
Pharmaceutical or Biotech environment
.
In-depth knowledge of sterile manufacturing processes, GMP, and cleanroom operations.
Hands-on experience in
supervising filling lines for PFS, vials, and cartridges
, including isolators and sterilization systems.
Familiarity with regulatory audits (e.g., WHO, USFDA, EU-GMP) preferred.
Skills & Competencies:
Strong leadership and people management skills.
Excellent knowledge of aseptic techniques, sterilization processes, and injection molding operations.
Sound understanding of QMS, validation, and documentation practices.
Proficient in MS Office and ERP systems.
Strong analytical, troubleshooting, and communication skills.
Email:
recruiter.vpj@gmail.com
WhatsApp:
+91 95414 20147
Job Type: Full-time
Pay: ₹1,000,000.00 - ₹1,600,000.60 per year
Work Location: In person
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