Pharma Packing Manager

Recruiter Details

Mohaneswara Reddy

https://www.linkedin.com/in/mohaneswarareddy

Role & responsibilities

Packing operation execution:

Check and monitor for cleanliness, maintenance, upkeep of the department, premises and equipment.

To ensure that all materials and finished products are stored under the appropriate conditions as per specification and in an orderly fashion to permit batch segregation and stock rotation.

To monitor and maintain correct status labelling of containers, equipments and materials.

To follow current Good Manufacturing Practice (cGMP).

Concurrent entries of all operations / activities, online documentation.

Handling of different packing activities includes line clearance of packing line, verification of cleaning, machine setting of equipment, reconciliation of packing material, rejection analysis.

Carry out inprocess checks and timely entries of data and completeness of Batch Packing Record.

Handling of SAP, Trackwise, CipDox, Goose system, documentum system as per role and right in system.

Handling of CENTRACK SERVER, PRAMAAN, LMS, E-Track, LEUCINE system as per role and right provided in System.

Handling of activity related to new product registration, site transfer product.

Handling of SOP, training, and related documentation.

Improvement, continuous review and up gradation of existing SOPs & work systems and to ensure their strict implementation.

Calibration of equipment, instruments and weighing balances, checkweigher as per schedule and maintaining records of the same.

PPM of equipment, instruments

Qualification of equipment, instruments

To conduct training of Staff & Workmen in the section.

Co-ordination with other sections and departments.

To maintain discipline in the department.

To carry out any other duties that may be allocated from time to time.

To protect product and material against spillage and deterioration.

To fill, evaluate and sign packing records before they are made available to Quality Assurance.

Review and sign on work order, batch packing record, standard operating procedure and other packing document as department head.

Review and sign Qualification, Requalification and related documents as department head.

Supervision and duty allocation to Staff & workmen in the section.

To track the inhouse calibration of equipment in the department.

Discussion of the day's work with Department Head.

Validation:

Participation in packing validation, process validation and cleaning validation in co-ordination with Quality Assurance.

Participation in study protocol and report activities, change part study and machine trial activity.

Quality Management System:

To document all changes through change request procedure in consultation with quality assurance.

To report deviations to department head and Quality Assurance.

To fill deviation in track wise system and carry out investigation and closure of deviations in timeline.

To carry out and review investigation of incidences / deviations / OOS / OOT / market complaints observed as per standard procedure.

To prepare, review of FMECA as team member and team leader.

Environment, Health & Safety

Strict adherence to safety, health and environment.

Monitoring safely operation the machine as per SOP, with minimum rejection & maximum output.

Preferred candidate profile

B.Pharma/M.Pharma with Pharma Packing experience of 10+ years