Senior Executive - QA

Umendra Life Sciences; Bavla; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Umendra Life Sciences in Gujarat, India, is seeking a QA/IPQA professional to manage day-to-day quality activities on the manufacturing and packing floors. You will perform line clearance, review batch records, and ensure strict GMP/GDP compliance.

The role includes CAPA, Change Control, and audits, with collaboration across Production, QC, and Engineering teams. Ideal candidates have 4–8 years in QA within regulated industries, strong documentation skills, and a proactive approach to data

Qualifications

• B.Pharm / M.Pharm / B.Sc / M.Sc with 4–8 years of relevant QA experience.
• Experience in Pharmaceutical, Cosmetic, Personal Care or regulated manufacturing industries preferred.
• Hands-on experience in AQA/IPQA, GMP compliance and batch documentation review.

Responsibilities

• Handle day-to-day AQA/IPQA activities in manufacturing and packing areas.
• Perform line clearance and verify manufacturing/packing operations.
• Review BMR, BPR and other batch-related documents.
• Ensure adherence to GMP, SOP, GDP and quality procedures.
• Monitor manufacturing processes and identify quality/GMP deviations.
• Initiate and support investigations for deviations, incidents, OOS/OOT and complaints.
• Prepare, implement and monitor CAPA and Change Control.
• Support process validation, cleaning validation and qualification activities.
• Review QA-related SOPs, protocols, reports and records.
• Participate in internal, customer and regulatory audits.
• Ensure timely closure of audit observations and compliance actions.
• Conduct GMP awareness and documentation training for plant personnel.
• Coordinate with Production, QC, Warehouse, Engineering and other departments.
• Maintain proper documentation and ensure data integrity.
• Ensure continuous improvement of the Quality Management System (QMS).

Skills

AQA/IPQA

GMP compliance

Line clearance

Deviation investigations

CAPA

Change Control

Process validation

Cleaning validation

QMS

Documentation

Audit readiness

SOP adherence

Data integrity

Cross-functional collaboration

Education

B.Pharm / M.Pharm / B.Sc / M.Sc

Job description

Role & responsibilities

• Handle day-to-day AQA/IPQA activities in manufacturing and packing areas.
• Perform line clearance and verify manufacturing/packing operations.
• Review BMR, BPR and other batch-related documents.
• Ensure adherence to GMP, SOP, GDP and quality procedures.
• Monitor manufacturing processes and identify quality/GMP deviations.
• Initiate and support investigations for deviations, incidents, OOS/OOT and complaints.
• Prepare, implement and monitor CAPA and Change Control.
• Support process validation, cleaning validation and qualification activities.
• Review QA-related SOPs, protocols, reports and records.
• Participate in internal, customer and regulatory audits.
• Ensure timely closure of audit observations and compliance actions.
• Conduct GMP awareness and documentation training for plant personnel.
• Coordinate with Production, QC, Warehouse, Engineering and other departments.
• Maintain proper documentation and ensure data integrity.
• Ensure continuous improvement of the Quality Management System (QMS).

Preferred candidate profile

• B.Pharm / M.Pharm / B.Sc / M.Sc with 48 years of relevant experience in Quality Assurance.
• Experience in Pharmaceutical, Cosmetic, Personal Care or regulated manufacturing industries preferred.
• Hands-on experience in AQA/IPQA, GMP compliance, line clearance and batch documentation review.
• Strong knowledge of cGMP, GDP and Quality Management Systems (QMS).
• Exposure to Deviation, CAPA, Change Control, OOS/OOT, Risk Assessment and investigation.
• Experience in process/cleaning validation and equipment qualification will be an added advantage.
• Good understanding of SOPs, BMR/BPR, audit compliance and data integrity.
• Strong documentation, analytical, communication and coordination skills.
• Ability to work effectively with Production, QC, Warehouse and Engineering teams.
• Candidates who can independently handle shop-floor QA activities and compliance requirements will be preferred.