Description
The role involves ensuring CGMP compliance and supervising overall production activities of manufacturing area during particular shift. Additionally, the position requires reviewing and maintaining online documents.
Essential Functions
- Responsible for preparation, review, revision, control, and implementation of standard operating procedures of sterile manufacturing department.
- Responsible for preparation and review of Protocols and reports based on the requirements.
- Responsible for Document management like BMRs, BPRs, Master SOPs etc..
- Responsible for the handling of Change Control, Deviations, CAPA, Investigation etc..
- To generate general purchase indent for departmental general items.
- Responsible for preparation of production planning on monthly and daily as per the requirement and availability of materials.
- Responsible to prepare daily production report as per the production achieved.
- Responsible to ensure that all equipment’s and lines are in validated and calibrated status.
- Responsible to follow cGMP, GDP, and discipline in the department and to ensure that all employees follow the same.
- Responsible to give training to all the subordinates, technicians, and operators of the department
- Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance.
- Responsible to attend the training as per training schedule and to ensure training as per TNI
- Responsible for preparation & review of the all-master documents of production .
- Responsible to ensure cleaning & sanitization and operation of machines as per Standard operating procedures .
- Responsible for Control and aseptic area operation like sterilization, manufacturing, washing & dehydrogenation, filling and sealing etc..
- Responsible for line clearance activity before commencing the operations like manufacturing, filling & sealing, labelling and packing operations .
Additional Responsibilities
- Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance.
- Responsible to give training to all the subordinates, technicians, and operators of the department. Responsible to update on self-hygiene.
- Responsible to attend the training as per training schedule and to ensure training as per TNI.
Education
QUALIFICATIONS
- Bachelors Degree (BA/BS) B. Pharm - Required
- Master Degree (MS/MA) M. Pharm - Preferred
- Master Degree (MS/MA) M. Sc. - Preferred
Experience
- 10 years or more in 10 - 15 Yrs
Skills
- Depyrogenation -Operation of depyrogenation tunnel supplied - Intermediate
- Filling, stoppering and sealing - Operation of glass vial/bottle filling and stoppering machine - Intermediate
- CIP & SIP - Operating skill for CIP/SIP skids - Proficient
- Dispensing - Handling and dispensing procedure for different type of materials - Proficient
- Sterilization Process by Autoclave - Proficient
- Mixing - Operation of mixing vessels - Intermediate
- Decartoning - Technique for Loading of glass vial / bottle - Intermediate
- Washing - Operation of glass vial/bottle washing machine supplied - Intermediate
- GMP Compliance & Documentation - Adhering to Good Manufacturing Practices (GMP) and regulatory norms (USFDA, EU, WHO) - Intermediate
- Filtration - Operation of filtration vessels supplied - Proficient
- Accurate and detailed record-keeping of every step in the injectable packing process - Proficient
- Ensuring all manufacturing equipment is calibrated and working within required parameters - Proficient
- Identifying and resolving issues with manufacturing equipment, ensuring minimal downtime - Proficient
- Performing cleaning and sanitization of packing machines, controlled area, and aseptic zones as per SOPs - Proficient
- Packing - Intermediate
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.
