Lab Qa Executive

Mankind Pharma; Sirmaur; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Mankind Pharma in India seeks an experienced QA professional for Laboratory Quality Assurance oversight.

You will ensure GMP/GLP compliance, review analytical data, and manage deviations, CAPA, change controls, and audits. The role requires 5–10 years in pharmaceutical QA, MSc or B.Pharm/M.Pharm, strong communication and documentation skills, and ability to coordinate cross-functional teams to sustain product quality and regulatory standards.

Qualifications

• Masters or Bachelor's in Pharmacy/Chemistry or Microbiology with 5–10 years in Pharmaceutical Quality Assurance.
• Experience in GMP/GLP and regulatory audits.
• Strong knowledge of CAPA, Change Control, OOS/OOT investigations and data integrity.

Responsibilities

• Ensure GMP/GLP compliance and regulatory requirements for lab activities.
• Review/approve analytical reports, raw data, specs, SOPs, protocols, and lab records.
• Investigate OOS/OOT, deviations, and lab incidents; perform root cause analysis (RCA).
• Monitor CAPA effectiveness and CAPA implementation.
• Review and approve change controls, risk assessments, and quality impact assessments.

Skills

GMP knowledge

GLP knowledge

Data integrity

CAPA

Change control

OOS/OOT investigation

Regulatory guidelines

Regulatory audits

Communication

Documentation

Root cause analysis

Quality systems

Education

M.Sc. in Chemistry or Microbiology

B.Pharm / M.Pharm

Job description

Role & responsibilities

• Ensure compliance of laboratory activities with GMP, GLP, data integrity, and regulatory requirements.
• Review and approve analytical reports, raw data, specifications, SOPs, protocols, and laboratory records.
• Investigate and manage OOS (Out of Specification), OOT (Out of Trend), deviations, and laboratory incidents.
• Perform root cause analysis (RCA) and monitor implementation and effectiveness of CAPA.
• Review and approve change controls, risk assessments, and quality impact assessments related to laboratory operations.
• Conduct internal audits and support regulatory inspections by FDA, MHRA, WHO, and customer audits.
• Ensure timely calibration, qualification, and maintenance compliance of laboratory instruments and equipment.
• Monitor training compliance of laboratory personnel and ensure adherence to approved procedures and quality systems.
• Maintain and improve the Laboratory Quality Management System (LQMS) through periodic reviews and compliance monitoring.
• Coordinate with QC, Production, Regulatory Affairs, and other cross-functional teams to ensure product quality and regulatory compliance.

Preferred candidate profile

• Qualification: M.Sc. (Chemistry/Microbiology) or B.Pharm/M.Pharm.
• Experience: 5-10 years in Pharmaceutical Quality Assurance, preferably in Laboratory QA.
• Strong knowledge of GMP, GLP, Data Integrity, CAPA, Change Control, OOS/OOT Investigation, and Regulatory Guidelines.
• Experience in handling regulatory audits and laboratory compliance activities.
• Good communication, documentation, and problem-solving skills.