Head Quality Assurance

Meyer Organics; Thane; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Meyer Organics in Thane, Maharashtra seeks an experienced Quality Assurance professional to lead IPQA, vendor qualification, and process validation in a pharmaceutical manufacturing environment.

You will oversee GMP compliance, QMS, CAPA, change control, audits, investigations, and cross-functional collaboration with Production, QC, R&D, Regulatory, and Supply Chain to drive continuous improvement.

Qualifications

• Strong hands-on experience in IPQA, Vendor Qualification, Process Validation, QMS, audits, investigations, CAPA and change control within a pharmaceutical manufacturing environment.

Responsibilities

• Lead and manage the overall Quality Assurance function across manufacturing operations.
• Oversee In-Process Quality Assurance (IPQA) activities and ensure GMP compliance.
• Plan, execute and review Process Validation / Process Qualification activities.
• Lead Vendor Qualification and Vendor Evaluation including approval, assessment, audits and re-evaluation.
• Establish and maintain effective Quality Management Systems (QMS).
• Review and approve SOPs, specifications, protocols, reports, deviations, CAPA, change controls and other quality documents.
• Ensure investigation and closure of deviations, incidents, OOS/OOT and market complaints.
• Oversee BMR/BPR review and release-related activities.
• Ensure timely implementation and closure of CAPA and Change Controls.
• Coordinate and lead internal, customer and regulatory audits/inspections.
• Ensure GMP and regulatory compliance; monitor quality trends and drive preventive actions.
• Work with Production, QC, R&D, Engineering, Regulatory Affairs, Supply Chain and other cross-functional teams to drive improvements.
• Lead, mentor and develop the QA team to achieve departmental quality objectives.

Skills

IPQA

Vendor Qualification

Process Validation

QMS

Audits

Investigations

CAPA

Change Control

GMP Compliance

BMR/BPR Review

Cross-functional Collaboration

Job description

The ideal candidate should have strong hands-on experience in IPQA, Vendor Qualification, Process Validation, QMS, audits, investigations, CAPA, and change control within a pharmaceutical manufacturing environment.

Key Responsibilities

• Lead and manage the overall Quality Assurance function across manufacturing operations.
• Oversee In-Process Quality Assurance (IPQA) activities and ensure compliance with approved procedures and GMP requirements.
• Plan, execute and review Process Validation / Process Qualification activities.
• Lead Vendor Qualification and Vendor Evaluation, including approval, assessment, audits and periodic re-evaluation of vendors.
• Establish, implement and maintain effective Quality Management Systems (QMS).
• Review and approve SOPs, specifications, protocols, reports, deviations, CAPA, change controls and other quality documents.
• Ensure effective investigation and closure of deviations, incidents, OOS/OOT and market complaints.
• Oversee Batch Manufacturing Record (BMR) / Batch Packing Record (BPR) review and release-related activities.
• Ensure timely implementation and closure of CAPA and Change Controls.
• Coordinate and lead internal, customer and regulatory audits/inspections.
• Ensure compliance with applicable GMP and regulatory requirements.
• Monitor quality trends, identify potential risks and implement preventive actions.
• Work closely with Production, QC, R&D, Engineering, Regulatory Affairs, Supply Chain and other cross-functional teams.
• Drive continuous improvement initiatives related to quality, compliance and manufacturing processes.
• Lead, mentor and develop the QA team to achieve departmental quality objectives.