Executive - QA

Umendra Life Sciences; Bavla; On-site; INR 650,000 - 850,000; Full time

Job summary

Umendra Life Sciences in Gujarat is seeking a QA/QC professional to coordinate Equipment Qualification, Cleaning Validation, Calibration, Stability Studies and related control sample management.

The role requires hands-on GMP/cGMP experience, protocol preparation, data integrity and timely documentation with cross-functional collaboration across Production, QC and external agencies.

Qualifications

• Experience in GMP/cGMP environments.
• Knowledge of QA documentation and records management.
• Understanding of deviation, CAPA, change control processes.
• Experience in qualification/validation protocols and reports.

Responsibilities

• Coordinate Equipment Qualification activities: protocols and reports.
• Manage Cleaning Validation protocols, sampling and reports.
• Coordinate Calibration of instruments per schedules.
• Maintain calibration records, certificates and due dates.
• Coordinate and manage Stability Study activities and documentation.
• Maintain Stability Data and Reports per GMP and protocols.
• Manage Control Samples: receipt, storage, reconciliation, destruction/retention.
• Ensure data integrity and traceability for QA activities.
• Coordinate with Production, QC, Engineering and external agencies.
• Ensure compliance with GMP/SOPs/protocols/regulatory requirements.
• Support audits and closure of observations.

Skills

Documentation skills

Attention to detail

Coordination

Data integrity

Regulatory awareness

Education

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

Tools

IQ/OQ/PQ protocols

Job description

Role & responsibilities

• Coordinate and execute Equipment Qualification activities, including preparation/review of qualification protocols and reports.
• Manage Cleaning Validation activities, including protocol execution, sampling, documentation and report preparation/review.
• Coordinate Calibration of instruments and equipment as per approved schedules and procedures.
• Maintain and monitor calibration records, certificates and due dates to ensure timely calibration.
• Manage Stability Study activities, including sample planning, storage condition monitoring, withdrawal schedules and documentation.
• Maintain Stability Data and Reports in compliance with approved protocols and applicable GMP requirements.
• Manage Control Samples, including receipt, identification, storage, reconciliation and destruction/retention as per SOP.
• Ensure proper documentation, data integrity and traceability for qualification, validation, calibration, stability and control sample activities.
• Coordinate with Production, QC, Engineering and external agencies for timely completion of QA activities.
• Ensure compliance with GMP/cGMP, SOPs, protocols and regulatory requirements.
• Support preparation for internal, customer and regulatory audits and ensure timely closure of observations.

Preferred candidate profile

• B.Pharm / M.Pharm / B.Sc / M.Sc with 35 years of relevant experience in Quality Assurance.
• Experience in Pharmaceutical / Cosmetic / Personal Care manufacturing preferred.
• Hands-on experience in Equipment Qualification, Cleaning Validation, Calibration, Stability Studies and Control Sample management.
• Good knowledge of GMP/cGMP, SOPs, GDP and Quality Management Systems (QMS).
• Experience in preparation, execution and review of qualification/validation protocols and reports.
• Knowledge of IQ/OQ/PQ, cleaning validation protocols, calibration schedules and stability study requirements.
• Ability to maintain accurate QA documentation, records and data integrity.
• Good understanding of deviation, CAPA, change control and risk assessment.
• Good coordination skills with QC, Production, Engineering and external agencies.
• Strong attention to detail, documentation skills and ability to meet timelines.
• Candidates with hands-on experience in regulated Pharma/Cosmetic manufacturing plants will be preferred.