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
Education:
Experience:
Specialized Knowledge: Licenses:
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
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Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.
