QA Job at Amneal Pharmaceuticals, Apply Now!
Join Amneal Pharmaceuticals in Ahmedabad, Gujarat, as a Senior Executive – QA. This is an exciting opportunity for professionals with quality assurance expertise to ensure compliance, validation, and risk assessment in manufacturing processes. Apply today and be part of a dynamic team!
- Job Position: Senior Executive – QA
- Location: Ahmedabad City, Gujarat, India
About the Company
Amneal Pharmaceuticals is based in Ahmedabad City, Gujarat, India, is seeking a Senior Executive – QA to join our team. We are dedicated to ensuring quality assurance and compliance in all our processes.
Job Description
Senior Executive QA Opportunity Responsibilities:
- Responsible for document handling, issuance, distribution, and retrieval of docume,verification of documents like Batch Manufacturing records, Batch Packaging
- Records, Protocols, layouts, specifications, Method of Analysis, Logbooks, Planner, etc.
- Responsible for issuance of approved Standard Formats and Logbooks to User Departments, Issuance of line-clearance checklist, interventions checklist and additional pages of BMR/ BPR as requested by user, reconciliation, retrieval and archival of issued standard formats and logbooks.
- To handle the proposed changes as per the change control procedure. To assess the risk / impact associated with proposed change and to verify the implementation of action plan as per approved change control form.
- To determine the investigation plan and carry out investigations using appropriate root cause analysis tools, assessing the risk associated with them, to perform the additional studies and to derive the appropriate CAPA.
- To handle the recommended CAPA and to verify the implementation of recommended actions as per CAPA system and to evaluate effectiveness checks of implemented CAPA.
- To perform the trend analysis of deviation, change control, complaints etc.. to identify any repetitive event for further evaluation and CAPA.
- Responsible for review of URS, DQ and vendor/ suppliers’ documents related to qualification.
- Responsible for preparation and review of Validation/ Qualification protocol and report.
- Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities.
- Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities
- Responsible for preparation and review of media fill and hold time protocol and report.
Responsible for preparation of Standard Operating Procedures of Quality Assurance Department. - Responsible for assessment of Change Control, Deviation, CAPA, Investigation etc..
- Responsible to prepare protocols of process validation and cleaning verification/validation.
- Responsible to conduct sampling activity as per the protocols (Process validation and cleaning validation etc..)
- Responsible for preparation, review and execution of risk assessment activity related to equipment/ process/ facility/ system
Senior Executive QA Opportunity Qualifications:
- B.Sc / M.Sc / B.Pharm / M.Pharm
Why Join Us?
- Industry Leader: Work with a reputed pharmaceutical company in Ahmedabad.
- Career Growth: Opportunities to develop expertise in QA, validation, and regulatory affairs.
- Cutting-Edge Environment: Gain hands-on experience with advanced quality control processes.
- Collaborative Work Culture: Work alongside highly skilled professionals in the pharmaceutical industry.
Keywords: Senior Executive QA, Ahmedabad City, Gujarat, India, Quality Assurance, Validation, Qualification, Process Validation, Compliance. QA Job at Amneal Pharmaceuticals, Apply Now!
