HITEC City, Hyderabad, Telangana

Job details
Salary
₹3,00,000 - ₹5,00,000 a year
Job Type
Full-time
Regular / Permanent
Full Job Description

Quality Assurance Associate

Job Description:

As the Quality Assurance Associate, you will be responsible for the maintenance of the QA function and ensuring compliance according to GMP (Good Manufacturing Practice) and will perform activities to assure compliance with applicable regulatory requirements by conducting audits, supporting training programs, data and documentation reviews.

Responsibilities:

Manage the GMP Documentation, Change Control, OOS, Deviations & Training Record systems.
Review and approve certificate of analysis (COA ) and Lab test reports and other quality documentation.
Oversee Quality Control documentation to enforce good documentation practice to improve accuracy, GMP compliance and neatness of analytical documentation
Verify calculations and documented information such as expiry, instrument calibration, logbook entries, control charts etc are present and complete and accurate.
Review internal logbooks for incoming samples, standards, equipment usage logs etc.
Track tests in progress and issue periodic status reports
Support training initiatives by implementing training program, including monitoring effectiveness of program and ensure training records are compliant
Periodic review of training records, SOPs, Change Control implementation, Deviation and OOS investigation
Tracking document requests and ensure completion of outstanding items
Conduct QA investigation regarding Out-of-Specifications, Exceptions and Corrective Action. Monitor effectiveness of corrective and preventative actions.
Issuance of batch documents for manufacturing and packaging.
Review batch production records and preparation of release certificates.
Release raw materials and packaging materials for dispensing.
Review production/packaging logbooks for completeness and provide feedback, where applicable.

Education and Experience:

Bsc- Science.
Previous experience in the food, consumer packaged goods or pharmaceutical industry an asset.
Must have excellent organizational skills to meet frequent changes in immediate priorities, problem solving skills, and understanding of various computer software programs required.