Group Lead - DPQA

Vizen Life Sciences Pvt Ltd; Hyderabad; On-site; INR 3,000,000 - 5,200,000; Full time

Job summary

Vizen Life Sciences Pvt Ltd in Hyderabad seeks an experienced Quality Assurance leader to oversee Drug Product manufacturing activities, including aseptic processing, filling, and packaging. You will ensure cGMP, GDP, and data integrity on the shop floor, review batch records, and support timely release.

The role requires 15-20 years in biopharma/aseptic manufacturing, with at least 5 years in QA leadership and proven exposure to global regulatory inspections (USFDA, EMA, etc.).

Qualifications

• 15-20 years in Biopharmaceutical, Sterile Injectable, Vaccine, or Aseptic Manufacturing environments.
• Minimum 5 years of leadership experience in Drug Product Quality Assurance or Manufacturing Quality Assurance.
• Hands-on experience supporting global regulatory inspections including USFDA, EMA, MHRA, ANVISA, PMDA, Health Canada, or equivalent agencies.
• Strong experience in aseptic processing, contamination control strategy, sterility assurance, validation, and batch disposition.

Responsibilities

• Provide QA oversight for Drug Product manufacturing operations, including aseptic processing, filling, visual inspection, and packaging activities.
• Ensure compliance with cGMP, GDP, Data Integrity (ALCOA+), and regulatory requirements on the manufacturing shop floor.
• Review and approve batch manufacturing records and support timely batch disposition and release.
• Act as authorized QA representative for product disposition decisions.
• Drive real-time quality oversight and escalation of critical compliance issues.
• Batch Release & Product Disposition – ensure all quality and GMP requirements are fulfilled prior to batch release.
• Review deviations, investigations, CAPAs, change controls, and impact assessments associated with product batches.
• Support risk-based decision-making for batch release, rejection, reprocessing, or rework.
• Review and approve market complaint investigations, recalls, and mock recall reports.

Skills

QA leadership

GMP compliance

Regulatory inspections

Data integrity ALCOA+

Job description

Responsibilities

• Manufacturing Quality Assurance
• Provide QA oversight for Drug Product manufacturing operations, including aseptic processing, filling, visual inspection, and packaging activities.
• Ensure compliance with cGMP, GDP, Data Integrity (ALCOA+), and regulatory requirements on the manufacturing shop floor.
• Review and approve batch manufacturing records and support timely batch disposition and release.
• Act as authorized QA representative for product disposition decisions.
• Drive real-time quality oversight and escalation of critical compliance issues.
• Batch Release & Product Disposition
• Ensure all quality and GMP requirements are fulfilled prior to batch release.
• Review deviations, investigations, CAPAs, change controls, and impact assessments associated with product batches.
• Support risk-based decision-making for batch release, rejection, reprocessing, or rework.
• Review and approve market complaint investigations, recalls, and mock recall reports.

Qualification & Experience

• 15-20 years of experience in Biopharmaceutical, Sterile Injectable, Vaccine, or Aseptic Manufacturing environments.
• Minimum 5 years of leadership experience in Drug Product Quality Assurance or Manufacturing Quality Assurance.
• Hands-on experience supporting global regulatory inspections including USFDA, EMA, MHRA, ANVISA, PMDA, Health Canada, or equivalent agencies.
• Strong experience in aseptic processing, contamination control strategy, sterility assurance, validation, and batch disposition.