Job Description

Postion : Manager - 1
Education : B. Pharm/M. Pharma
Experience : 10 to 20 Years
Will be responsible for packing department of sterile products.
Key Responsibilities:

• Responsible for packing department of sterile products.
• To ensure that completion of packing activity of transferred batches within given time line for packing department.
• Maintain All Time Compliance in packing department.
• To ensure that packing of the products performed in packing departments as per the defined standards and quality.
• Design the system and packaging facility to reduce the market complaints due to operation error.
• Implementation of cGMP practices, system development work and to maintain the consistency of practice of packaging facility.
• To ensure that, on time closure of QMS records (internal and external CAPA, Change Control, investigations, etc.) within original due date without any extension.
• To guide subordinates in context of controlling the functions related packing activity.
• Work allocation to the subordinates as per production planning.
• Co-ordination with other department like QA (For release), Ware house (For packing material), Engineering (For Equipment breakdown and preventive maintenance), HR (For manpower requirement), other packing area, PDD, new packing material development for Block-F first floor packing department.
• Co-ordination with NDDS department for new product related activities of sterile products of Halol for all concerned blocks.
• To plan and initiate for procurement of new machine /facility for sterile product packing.
• To make yearly budget and CAPEX for equipment and consumable items of sterile products of Halol for all concerned blocks.
• He will be responsible as Plan approver of CC, SOP, CAPA, DQ, URS, FAT and SAT.
• To make shift packing planning with co-ordination planning department.
• Involve in all kind of trouble shooting for machine under maintenance.
• Help to subordinates to standardize machine operation to achieve better efficiency and quality.
• To achieve productivity as per target norms of sterile products of Halol for all concerned blocks.
• To arrange training to all relevant persons as per SOPs & further required documents.
• To take out all LMS related training through LMS (Learning Management System).
• To generate and retrieve all relevant formats through EDMS (Electronic Data Management System).
• He will be responsible as Manager Reviewer of QMS Track wise system related activity like as Engineering change control while execution of qualification activity.
• He will be responsible as Manager reviewer of QMS Track wise system module as Change control, CAPA, Incident, Interim investigation, Effectiveness checks, Investigation, Extension, Action item.
• To ensure smooth conduct of internal and external quality audit.
• To review and approve DHF and DHR.
• Any other job assigned by the superiors to complete timely.

Tasks: * Will be authorized to sign (as an Authorized person or as a Department Head) :

• Learning Management System related records.
• Electronic Data Management System related records.
• SAP HANA System related records.
• Departmental SOPs.
• Batch Packing Records.
• Qualification protocols and reports.
• Training Records.
• Any GxP Reports.
• Handling of any other activities / tasks allotted by his superiors.