Sana - Executive

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

• To ensure timely completion of SOPs training and on the job trainings related to production department.
• To review and maintain the training related log books in the department.
• To Coordinate new joiners for internal and cross functional trainings in coordination with cross functional
  

departments.

• To coordinate with QA documentation cell for issuance of required documents and submission of
  

completed documents.

• To prepare the SOP index, Equipment index and format index as per the frequency of QA001,
  

QA007and QA002.

• To update the schedule manager for SOP related activities (to update SOP effective dates).
• To upload the SOPs in AIMS (Amneal information management software).
• To close the training record of employees who left the organization.
• Preparation of cGMP planner for contractual employees of production department.
• Operation and cleaning of visual inspection table and Operation of Lux meter.
• Responsible for Operation and cleaning of Automatic visual inspection machine and X-RAY inspection
  

machine.

• Responsible to perform visual inspection of the products /media filled vials or PFS as per the sop.
• Responsible for Maintenance of cleaning in visual inspection.
• Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by
  

Following HODs instructions and guidance.

• Monitoring of DP, RH and temperature area in their visual inspection and packing area.
• Responsible for Maintenance of cleaning in visual inspection and packing area.
• To maintain the BMRs and other log books in the visual inspection and packing area as per cGMP and
  

SOP.

• Operation and cleaning of dynamic pass box in visual inspection and packing area.
• Responsible for Operation and Cleaning of Wrap around labeling machine, Autocartonator machine,
  

Online check weigher, track and trace system, Bopp taping machine with weighing balance and PFS
packing area machines.

• Responsible for Dispensing, checking and receiving of the packing materials from warehouse on need
  

basis.

• Responsible for labeling and packing of products as per BPR.
• Responsible for timely completion of calibrations and validations in coordination with EN and QA related
  

to visual inspection and packing area.

• To handle Quality Management Documents like Change Control, Deviation etc.
  

Job Description Version No:4 Generated By/On: Sanjay Mukhekar [309175] 24-May-2025 12:47:40 PM
This is system generated document hence signature is not required. 1JOB RESPONSIBILITY

• 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 necessessory mitigation plans
  

through Quality Risk Management (QRM).

• To provide direct input or coaching support for other functional groups in investigations.
• 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 prepare BMR and BPR.
• Timely completion of SOPs training and On the job trainings related to respective area
  

Qualifications

Qualification - B.Pharmacy, M.Pharmacy

About Us

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.

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.