Amneal Pharmaceuticals, Inc is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business. Together, our team is working to build one of the most dynamic pharmaceutical companies in our rapidly changing industry.
Post : Officer/ Sr. Officer / Executive
QA (Validation & Qualification) Department
Qualification : B.Pharma / M.Pharma / B.E
Total Experience : 3 to 6 years in injectable/ sterile manufacturing plant with relevant experience.
Job Description :
1.Responsible for review of URS, DQ and vendor/ supplier’s documents related to Responsible for review of URS, DQ and vendor/ supplier’s documents related to qualification.
2 Responsible for preparation and review of Validation/ Qualification protocol and report
3 Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities
4. Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities.
5. Responsible for preparation and review of media fill and hold time protocol and report.
6. Responsible for preparation of Standard Operating Procedures of Quality Assurance Department.
7.Responsible for assessment of Change Control, Deviation, CAPA, Investigation etc
8. Responsible to prepare protocols of process validation and cleaning verification/validation.
9. Responsible to conduct sampling activity as per the protocols (Process validation and clearing validation etc.).
10. Responsible for preparation, review and execution of risk assessment activity related to equipment/ process/ facility/ system
QA - QMS (Market Complaints & Investigation) Department
Experience : 04 - 7 Years
Position : Executive / Senior Executive
Job Location : Ahmedabad (SEZ - Matoda)
Function : Quality Assurance (QA) - QMS
Note :
1. Candidate should have 4 - 7 years experience in QA department in injectable/ sterile manufacturing facility.
2. Candidate should have exposure of handling QMS, market complaints & investigation report preparations regarding the same.
Candidate with good communication & interpersonal skills, computer knowledge and understanding of regulatory requirement will be preferred.
Interested candidates can share their CV on ajaykumar.pandey@amneal.com with the subject line
"Application for "QA - Validation Department", Application for QA - QMS Department
Last Date : 20th June, 2023
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