Job Description

To follow safety rules in the premises according to the company norms.

Responsible to perform the CIP & SIP and VLT of lyophilizer.
Participating in Lyo loading & unloading the activities
Responsible to perform the in process checks during operation.
To ensure aseptic area cleaning and fogging to coordinating with engineering department as per the schedule
Responsible for the co-ordination with cross functional departments like QA, QC, warehouse Engineering, HR and administration for day to day activities.
Responsible for timely completion of calibrations and validations in coordination with engineering and QA related to Lyophilization and area.
To maintain the BMRs and other log books in the Lyophilization area as per cGMP and SOP.
Preparation and periodic revision of SOPs related to area.
Responsible for the operation and cleaning of lyophilizer area.
Cleaning and sanitization of Lyophilization area drain points.
Responsible to carry out the lyophilization area operations as per the SOP and BMR.
Operation and cleaning of glove integrity and filter integrity testers.
Responsible for Dispensing, checking and receiving of PPM from warehouse on need basis.
Preparation, filtration and issuance of disinfectant and deactivation solutions to all the sections in the production area.
Responsible for cleaning and storage of all the filling machine accessories and change parts.
Operation and cleaning of table mounted LAF and Ceiling mounted LAF
Operation and cleaning of steam sterilizer and HPHV steam sterilizer.
Preparation of loads meant for Autoclaving like garments, disinfectant, filling, filtration, rubber stopper and seals for sterilization as per the validated load pattern.
Responsible for monthly frequency activity.
Responsible for ensuring garments washing, drying and Folding activities.

Responsible for line clearance before start of the Activity.

Timely completion of SOP's training and on the job trainings related to Lyophilization area , Component preparation and sterilization area (Autoclave area).
Monitoring of DP, RH and temperature area in their Component preparation and sterilization area (Autoclave area).
Responsible for operation Maintenance and cleaning of Component preparation and sterilization area.

Qualifications

QUALIFICATION - B.SC, B.Pharmacy

About Us

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

About The Team

The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key Roles That The Human Resources Team Performs

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.

Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.

Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.

Consultancy Role: Provide expert advice to the organization and it's managers on any aspect of workforce management and employee relations and performance.

Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.

Officer, Autoclave

Regulatory Affairs Specialist

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Engineering Executive – Process Instrumentation