Responsibilities: To ensure cGMP compliance in packing department. To oversee and manage the packing process and ensure products are packed accurately, efficiently and on time. Products are delivered in accordance with quality standards. To forecast man day requirement as per monthly plan and shift scheduling, Assigning work to packing staff and monitoring quality of products packed. To co-ordinate with other functional department – (A) Packing purchase for packing materials supplies in time. (B) Warehouse for day to day packing material dispensing. (C) Quality Assurance and Quality Control for release of packing material. (D) Engineering Department for any breakdown or any area related work. (E) Coordinate with the manufacturing team to ensure products are manufactured (F) As per rolling plan and according to required specifications. To co-ordinate with Human resource department for selection and interviewing the personnel, fulfill vacancies in department and to ensure cGMP compliance is followed in respective departments. To co-ordinate with packaging development team and different vendors for designing and manufacturing of change parts, new machines as per User requirement specifications and other machine parts as per requirement. To review process validation protocol & report, involve in IQ/OQ/PQ/DQ with its documents and ensure effective execution of all process activities. To review that all the packing and manufacturing activities are carried out as per laid down procedure and batch records (BMP/BPR). Maintain packing budget to ensure that costs are controlled while maintaining high-quality standards. To maintain confidentially all company documents and intellectual properties and ensure compliance with all health and safety regulations. To Review master Batch packing record, BOM and other related documents. Determine the Materials resources required and indent on monthly/ quarterly basis. Manage Human resources on weekly and monthly basis to meet packing targets. Co-ordination for equipment usage, maintenance modification and procurement with respective departments. To ensure that all the activities of shop floor carried out in accordance with cGMP as per laid down procedures in SOP, BPRs & FDA guidelines. Monitor all software used in packing are in working mode and used (E log, EQMS, LMS, EDCS). Implement and enforce quality control and Tracking to meet quality objective. Determine and implement improvements to the packing process. Monitor and review the performance of staff and organize necessary intention for Improvement. Implement cost control training to staff persons. To ensure timely initiation and completion of any EQMS tasks (change control, incidents, deviation and CAPA) taken in for any non-compliance on the shop floor or for any market complaint with proper investigation, justification and conclusion. To ensure that entry & exit procedures, gowning (primary & secondary, colour code) procedures, personnel hygiene procedures are strictly followed in department. To evaluate and impart training in departmental /cross functional person. To review and approve all departments Standard Operating Procedures.
Job Title
Assistant Manager Packing