Job Description

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:

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:

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.