- To carry out and supervise the secondary packaging / Pen Assembly line operations with all necessary documentation as per the defined procedures.
- To provide day to day technical assistance related to production equipment to finished production team to have uninterrupted packaging / Qualification process in a safe and quality compliant way.
- To actively participate in the departmental new projects and to ensure the timely completion of the tasks/project milestone assigned by Team leader / Manager as per project timeline.
- To train all finished production operators on new/existing production equipment with special reference to the troubleshooting, cleaning, and maintenance.
- To monitor the progress of assignments on daily basis given to operators and provide feedback to superior/Manager in daily meetings.
- To actively participate in qualification activities like FAT, SAT, DQ, IQ, OQ, and PQ etc for existing and new equipment.
- To participate in preparation and review of the finished production documents like, SOPs, BPRs, investigation reports and protocols including validation and qualification protocols.
- To coordinate with department QMS representative in Change Control and Deviation /VNC handling as per requirement and their timely closure.
- Effective CAPA Management with SMART and robust CAPA proposals and timely closure.
- KPIs update for effective performance management.
Qualifications & Experiences
- Bachelor of Pharmacy or Master’s in science
- Minimum 4 Years of experience in the same field in Pharma/Biotech Manufacturing Industry.
- Business Results Oriented
- Excellent Leadership and Management
- Excellent Team Development
- Expert Intercultural Sensitivity
- Highly Proactive and Expert in Acting with Urgency
- Excellent collaboration and Influencing
- Good command in English Language (Verbal and Written)
- Expert in working with Automatic lines, machines / Latest Packaging Technology
- Good Hands on experienced on SAP /ERP / MS Office /QMS software