Plant Head - Formulations

Digvijaya Management; NTR; On-site; INR 4,000,000 - 6,000,000; Full time

Job summary

Digvijaya Management invites an experienced professional to head the OSD manufacturing plant. The role oversees operations from dispensing to packing, ensuring safety, compliance, and cost-efficient production.

The candidate should hold B.Pharmacy or M.Pharmacy with 22–25 years of plant operations experience in an USFDA-approved OSD facility, driving continuous improvement and coordination with QA/QC and regulatory teams.

Qualifications

• Candidate must have B.Pharmacy or M.Pharmacy with 22–25 years of experience in plant operations of an OSD manufacturing facility approved by USFDA.

Responsibilities

• Provide overall leadership for the OSD manufacturing plant and ensure safe, compliant, efficient operations.
• Drive manufacturing operations covering dispensing, granulation, compression, coating, encapsulation, packing, and related activities.
• Ensure continuous compliance with USFDA, cGMP, WHO-GMP and other applicable regulatory requirements.
• Lead plant readiness for USFDA inspections, regulatory audits, customer audits and internal quality audits.
• Ensure timely closure of observations, CAPAs, deviations, change controls and regulatory commitments.
• Partner with Quality Assurance/Quality Control to strengthen quality culture and right-first-time manufacturing.

Skills

Leadership

Regulatory compliance

Manufacturing operations

Education

B.Pharmacy

M.Pharmacy

Job description

Candidate should be B.Pharmacy/M.Pharmacy with 22 to 25 years of experience in Plant operations of OSD Manufacturing facility approved by USFDA.

• Provide overall leadership for the OSD manufacturing plant, ensuring safe, compliant, efficient, and cost-effective operations.
• Drive manufacturing operations covering dispensing, granulation, compression, coating, encapsulation, packing, and related activities.
• Ensure continuous compliance with USFDA, cGMP, WHO-GMP and other applicable regulatory requirements.
• Lead plant readiness for USFDA inspections, regulatory audits, customer audits, and internal quality audits.
• Ensure timely and effective closure of observations, CAPAs, deviations, change controls and regulatory commitments.
• Partner closely with Quality Assurance and Quality Control to strengthen the site's quality culture and right-first-time manufacturing.
• Drive OEE improvement, productivity enhancement, yield improvement, capacity utilization and reduction of manufacturing losses.
• Develop and execute annual operating plans, manufacturing budgets and cost-reduction initiatives.
• Ensure adherence to production plans while maintaining product quality, safety and delivery commitments.
• Lead Engineering, Maintenance and Utilities to ensure equipment reliability, preventive maintenance and uninterrupted production.
• Work closely with Supply Chain, PPIC, Warehouse, QA, QC, R&D, Regulatory Affairs and Commercial teams.
• Identify and implement continuous improvement / Lean / Six Sigma initiatives across the plant.
• Ensure robust systems for data integrity, documentation, batch record compliance and good documentation practices.
• Establish and monitor appropriate KPIs for safety, quality, productivity, delivery, cost and employee performance.
• Develop a strong second line of leadership and build a high-performance manufacturing team.
• Ensure compliance with EHS, statutory and occupational safety requirements.
• Drive technology adoption, automation and modernization of manufacturing operations wherever appropriate.
• Support new product introductions, technology transfers, scale-up and capacity expansion.
• Act as the key site leader and interface with senior management, regulatory agencies, customers and other stakeholders.