Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a global pharmaceutical company. Our development, manufacturing, and distribution of a diverse portfolio of 270+ high-quality medicines, team of 7,500+ colleagues helps make healthy possible through.
Post : QMS Senior officer
Job Description
• To follow the safety rules in the premises according to the company norms.
• To handle Quality Management Documents like Change Control, Deviation etc.
• To prepare Failure Investigation Reports against Quality impacting deviations, Out-of- Specifications and Non-Conformances.
• To ensure investigations are evaluated and closed out in a timely manner to meet business needs.
• Responsible for cGMP compliance related to CAPA implementation and to ensure the timely closure of CAPA.
• To review, develop and introduce systems, practices and cultural changes that enable the department to meet business demands within agreed time frames and expected GXP standards.
• To perform risk analysis for different process or procedures and implement necessary mitigation plans through Quality Risk Management (QRM).
• To provide direct input or coaching support for other functional groups in investigations.
• To conduct internal audits as per laid down schedule with different function.
• To prepare and review of Standard Operating Procedures / Protocols.
• To perform Gap analysis of defined procedures in Batch Manufacturing Record / Batch Packing Record / Standard Operating Procedure / Protocol and initiation of corrective actions.
• To participate in Regulatory & Customer Audits.
• To evaluate & investigate Market complaints.
• To provide training to subordinates for different processes / procedures.
• Responsible for intra and inter coordination with different functions.
• To prepare BMR and BPR.
• Timely completion of allotted Sop s training.
• Preparation and periodic revision of SOPs related to QMS area.
• Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instructions and guidance.
Candidate Profile : Bachelor Degree with 3 years experience
Additional Information
Experience : 3 years
Qualification : Bachelor Degree
Location : Hyderabad, Telangana
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : QMS
Job Category : Manufacturing Process Operations
End Date : 31st October 2025
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