Assistant Production Manager

Role & responsibilities

Responsible for manufacturing Operation like API manufacturing

Sterile API manufacturing by aseptic

process, Purification by preparative HPLC, Peptides.

• Managing all shift activities like Day-to-Day batch planning, in-

process checks with team, dispensing, packing, repacking of API.

• Responsible to trained subordinate, colleagues.
• Implementing and achieving highest standard of cGMP and WHO.
• Excellent communication with all inter-departments like warehouse,

QC, QA, Engineering, R&D, PD Lab and ARD for smooth functioning

and execution of production activities.

• Trouble shooting during execution of pre-validation batch and finding

robust solutions for the problems before validation batches to avoid

the failures and to get consistent yield and quality at commercial

scale.

• Ensure all time Plant readiness for inspections, audits by customer

and regulatory authorities.

• Recruit and train successful multi-cultural teams with latest

knowledge & modern skills in technical support fields to deliver quality

services.

• Selection of the suitable equipments, maintain and upgrade

manufacturing facility as per Production, safety and cGMP

requirement.

• Monitoring safe work environment and maintain good house keeping.
• Documents preparation, Review like SOP, MBR, ECR, Protocol,

Reports, Qualification.

• Responsible for QMS Activity (Change control, Deviation, CAPA, Risk

Assessment).

• Responsible for Qualification activity of Isolator (Closed Containment

System), Autoclave, SIP process, VHP cycle.

• Responsible for process designing of Media fill accordance to New

Product Introduction