Senior Executive, filling & sealing

Amneal Pharmaceuticals; Hyderabad; On-site; INR 300,000 - 500,000; Full time

Job summary

Amneal Pharmaceuticals is seeking a dedicated professional to operate in the aseptic filling area. You will follow safety rules, monitor DP, RH and temperature, and maintain BMRs and log books in accordance with cGMP and SOPs.

The role involves operating and cleaning filling area equipment such as filling machines, performing in-process checks, coordinating with QA/QC and engineering, and ensuring timely completion of calibrations and validations.

Qualifications

• Undergraduate ITI mandatory.
• Diploma DBM preferred.
• 2+ years of experience in aseptic/pharmaceutical manufacturing.

Responsibilities

• Follow safety rules in premises according to company norms.
• Monitor DP, RH and temperature in aseptic processing area.
• Maintain BMRs and log books in aseptic area per cGMP and SOP.
• Operate and clean area equipment in filling area (e.g., filling machine).
• Carry out filling, stoppering, lyophilization and sealing operations per SOP/BMR.
• Perform in-process checks during filling.
• Aseptic area cleaning and fogging coordinating with engineering.
• Operate and clean all aseptic equipment, change parts and storage per procedure.
• Operate heating/cooling skid, CIP & SIP skid.
• Environmental monitoring of viable aseptic area.
• Coordinate with QA, QC, warehouse, engineering.
• HR and administration for day-to-day activities.
• Complete calibrations and validations in coordination with engineering and QA.

Education

Undergraduate ITI - Required

Diploma DBM - Preferred

Job description

• To follow safety rules in the premises according to the company norms
• Monitoring of DP, RH and temperature in aseptic processing area
• To maintain the BMRs and other log books in the aseptic processing area as per cGMP and SOP
• Responsible for operation and cleaning of area equipment present in the filling area like filling machine,

Job Description

Job Responsibility

• To follow safety rules in the premises according to the company norms
• Monitoring of DP, RH and temperature in aseptic processing area
• To maintain the BMRs and other log books in the aseptic processing area as per cGMP and SOP
• Responsible for operation and cleaning of area equipment present in the filling area like filling machine,

Rubber stoppering, sealing machines, Isolators, Pass boxes, Glove cleaning and integrity testers including VHP.

• Responsible to carry out the filling, stoppering, lyophilization and sealing operations as per the SOP and

BMR

• Responsible to perform the in process checks during filling.
• To perform aseptic area cleaning and fogging to coordinating with engineering department as per

schedule

• Operation and cleaning of all Aseptic area equipment, change parts and storage as per the procedure.
• Operation and Cleaning of heating cooling skid, CIP & SIP skid.
• Responsible for environmental monitoring of (Viable) aseptic processing area
• 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 aseptic processing area.

• Responsible for cleaning verification and preparation of filling parts for autoclaving
• Timely completion of SOPs training and on the job trainings related to aseptic processing area.
• Operation and cleaning of all equipments like CIP / SIP for vessels before starting of the batch process

and after completion of the batch process related to filling and filtration.

Education

QUALIFICATIONS

• Undergraduate ITI - Required
• Diploma DBM - Preferred

Experience:

• 2 years or more in 2 - 5 Years

Specialized Knowledge:

Licenses:

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.