Assistant Manager, Quality Assurance at Amneal India

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

25 Sep, 26

Salary

0.0

Posted On

27 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Risk Assessment, CAPA, Root Cause Analysis, cGMP, GDP, Vendor Management, Change Control, Audit Coordination, SOP Preparation, Quality Risk Management, Compliance Auditing

Industry

Pharmaceutical Manufacturing

Description

Description: Responsible for implementation of approved procedures and responsible for system and facility compliance audits. •To conduct or be part of team conducting risk assessment of various activities, equipment, systems, etc. in the location •Responsible for assessment and logging of Deviation, CAPA •To carry out investigations to the deviations, market complaints, OOS, OOTs, etc. by using appropriate root cause analysis tools, assessing the risk associated with them and ensuring compliance of the non conformances as per the cGMP by documenting it through the CAPA system. •To carry out self inspection activity as per Procedure •To prepare Quality management review report •To impart training on Mandatory training topics like cGMP, GDP etc. •To review updated guidelines and informs gaps in the current practices to respective department heads and quality assurance head for its compliance. •To evaluate and respond to customer / regulatory queries / observation related to documents •Approval of document request forms received from various departments. •To prepare standard operating procedures of Quality Assurance Department and review the SOPs of cross functional departments. •To handle the Quality risk management activities, follow-ups, status updation and approval of the QRMs’. •To handle of Contract service agreement documentation activities, follow-ups, updation of status and annual planner preparation. •To handle the vendor management activities. Review of vendor qualification documents and updation of approved vendor list. •Responsible for review of material code creation request form. •To update the List of deactivating agents and deactivation procedure as per R & D recommendation. •Responsible to check production shop floor compliance. •To handle the changes carried out in the location by assessing the risk associated with it as per the change control procedure. •To co-ordinate regulatory / customer audits conducted at the location, recording the day to day activities, informing the same to the management, coordinate with respective department for online compliances (if required) and provide the compliance to the audit observations by coordinating with respective departments and guidance of the HOD within the stipulated timeline. •Responsible for initiation and Closing of Change Controls

Responsibilities

Responsible for implementing quality procedures, conducting facility compliance audits, and managing risk assessments. Oversees the investigation of deviations, market complaints, and the execution of CAPA systems to ensure cGMP compliance.