Officer, QA Validation at Amneal Pharmaceuticals, Ahmedabad
The Amneal QA Validation Job is an opportunity for qualified candidates to join Amneal Pharmaceuticals as an Officer in QA Validation. This position is based in Ahmedabad and requires candidates with 2-5 years of relevant experience. The role involves critical responsibilities in ensuring the quality and compliance of sterile manufacturing processes.
About the Company
Amneal Pharmaceuticals is a global pharmaceutical company that specializes in the development, manufacturing, and distribution of generic and specialty pharmaceuticals. With a commitment to quality and innovation, Amneal operates in various therapeutic areas and is dedicated to improving patient outcomes through accessible healthcare solutions.
Job Details:
- Position: Officer, QA Validation
- Location: Ahmedabad
- Experience Required: 2-5 years
Amneal QA Validation Job Description
The Officer in QA Validation will be responsible for preparing, executing, compiling, and reviewing URS, DQ, IQ, OQ, and PQ protocols and reports for various sterile manufacturing equipment. In this QA validation role, this includes involvement in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to ensure compliance and quality standards are met before the initiation of Installation Qualification (IQ).
Key Responsibilities
- Prepare, execute, compile, and review URS, DQ, IQ, OQ, and PQ protocols and reports for sterile manufacturing equipment.
- Participate in Factory Acceptance Test and Site Acceptance Test for new equipment, ensuring closure of findings before IQ begins.
- Qualify and requalify HVAC systems and classified areas, including air velocity, HEPA filter integrity, and particle counts.
- Coordinate and review airflow visualisation studies for Grade A zones, retaining recordings as qualification evidence.
- Qualify and requalify utilities such as Purified Water and compressed air, including periodic review of trending data.
- Maintain the site Validation Master Plan and annual validation schedule, flagging due items to the reporting manager.
- Verify calibration, preventive maintenance, and instrument traceability status before execution of qualification studies.
- Prepare and maintain the traceability matrix linking user requirements to qualification test cases and acceptance criteria.
Eligibility Criteria
- B.Pharm, M.Pharm, M.Sc. (Chemistry or Microbiology), or B.E. / B.Tech in Biotechnology or Chemical Engineering.
How to Apply
Interested candidates can apply for the position by following the link below:
CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
Amneal QA Validation Job: Conclusion
The Amneal QA Validation Job is an excellent opportunity for qualified individuals to contribute to the quality assurance processes at Amneal Pharmaceuticals. Candidates who meet the eligibility criteria are encouraged to apply before the deadline to seize this opportunity for professional growth.
