Manager, Manufacturing Injectables

Job Description

Responsible to update on self-hygiene.

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.

Skills

Complying with Good Manufacturing Practices (GMP) and regulatory standards (USFDA, MHRA, WHO, etc.).

Completing Batch Packing Records (BPRs), logbooks, and deviation reports.

Maintaining traceability and following SOPs strictly

Qualifications

M.Sc. / B.Pharm / M.Pharm