Quality Assurance Manager

Glowria Lifecare; Neemrana; On-site; INR 2,500,000 - 5,000,000; Full time

Job summary

Glowria Lifecare is seeking a senior QA leader to drive GMP compliance and PQMS across the organization. You will establish policies, review critical quality records, and oversee CAPA, change control, and investigations to safeguard product quality.

You will lead internal audits, coordinate regulatory inspections, and mentor teams in data integrity, risk management, and continuous improvement initiatives within a fast-moving pharmaceutical environment.

Qualifications

• 15 to 18 years of experience in Pharmaceutical QA, with managerial experience.
• Strong knowledge of GMP, GLP, GDP, Data Integrity, and regulatory requirements.
• Hands-on experience in QMS, deviations, CAPA, change control, OOS/OOT, and risk management.
• Experience in batch release, validation, audits, inspections, and product complaints/recalls.
• Strong leadership, decision-making, analytical, and problem-solving skills.
• Excellent documentation, communication, and team-management skills.
• Ability to ensure regulatory compliance and continuous quality improvement.

Responsibilities

• Overall responsibility for GMP compliance and the PQMS.
• Establish, implement, and monitor quality policies, procedures, SOPs, and quality standards.
• Review and approve BMR/BPR, specifications, protocols, reports, and other quality documents
• Ensure proper handling of deviations, OOS/OOT, CAPA, change controls, and investigations
• Review and approve batch records and product release as per approved specifications.
• Oversee validation and qualification of processes, equipment, cleaning, and systems.
• Manage market complaints, product recalls, and mock recalls.
• Plan and conduct internal audits and coordinate customer/regulatory inspections.
• Ensure compliance with GMP, GDP, data integrity, and applicable regulatory requirements
• Monitor vendor qualification and quality agreements where applicable.
• Ensure effective training and GMP awareness of employees.
• Review quality trends, risk assessments, and periodic quality reports
• Coordinate with QC, Production, Warehouse, Engineering, and Regulatory Affairs on quality matters.
• Promote continuous improvement and a strong quality culture throughout the organization.

Skills

GMP knowledge

Quality management

Regulatory compliance

Documentation

Leadership

Risk assessment

Audits

Education

B.Pharm/M.Pharm/M.Sc. in Pharmacy or related discipline

Tools

QMS system

CAPA tracking

Change control

Job description

Role & responsibilities

• Overall responsibility for GMP compliance and the Pharmaceutical Quality Management System (PQMS).


• Establish, implement, and monitor quality policies, procedures, SOPs, and quality standards.


• Review and approve BMR/BPR, specifications, protocols, reports, and other quality documents.


• Ensure proper handling of deviations, OOS/OOT, CAPA, change controls, and investigations.


• Review and approve batch records and product release as per approved specifications.


• Oversee validation and qualification of processes, equipment, cleaning, and systems.


• Manage market complaints, product recalls, and mock recalls.


• Plan and conduct internal audits and coordinate customer/regulatory inspections.


• Ensure compliance with GMP, GDP, data integrity, and applicable regulatory requirements.


• Monitor vendor qualification and quality agreements where applicable.


• Ensure effective training and GMP awareness of employees.


• Review quality trends, risk assessments, and periodic quality reports.


• Coordinate with QC, Production, Warehouse, Engineering, and Regulatory Affairs on quality matters.


• Promote continuous improvement and a strong quality culture throughout the organization.

Preferred candidate profile

• B.Pharm/M.Pharm/M.Sc. in Pharmacy, Chemistry, or related discipline.


• 15 to 18 years of experience in Pharmaceutical QA, with managerial experience preferred.


• Strong knowledge of GMP, GLP, GDP, Data Integrity, and regulatory requirements.


• Hands-on experience in QMS, deviations, CAPA, change control, OOS/OOT, and risk management.


• Experience in batch release, validation, audits, inspections, and product complaints/recalls.


• Strong leadership, decision-making, analytical, and problem-solving skills.


• Excellent documentation, communication, and team-management skills.


• Ability to ensure regulatory compliance and continuous quality improvement.