Senior Officer, QMS

Amneal Pharmaceuticals

4 - 7 years

3 - 4 Lacs

hyderabad

Posted:2 weeks ago| Platform:

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Skills Required

batch manufacturing market complaints internal audit standard operating procedures packaging gap analysis risk management customer audits risk analysis quality management

Work Mode

Work from Office

Job Type

Full Time

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

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