Job Description
Roles and Responsibilities
1. Responsible for all sections of production area and plan and execute production to meet business requirements within timelines.
2. Ensure data integrity and compliance to quality and regulatory requirements at all times. Also ensure that entry/exit, preparation and autoclave, CIP, SIP, formulation, filtration, vial washing, depyrogenation, filling, sealing, Lyophilizer loading/unloading activities are carried out in compliance with the cGMP requirement and as per respective SOPs. Maintain the change parts, spares which are required for all the equipments of the production areas.
3. Ensure continuous monitoring of BMS i.e. temperature, differential pressure, relative humidity, PMS and their compliance.
4. Handling of manpower and allocating defined responsibilities to the team in production areas. Micro planning of shift activities of the day, conveying the work flow to the team and taking follow ups for progress of assigned work.
5. To ensure discipline in the team and aseptic practices are compliant always.
6. To coordinate with compliance team and QA-QMS for documents i.e. change controls, CAPA, Deviations, QRA, Technical document, Study Protocols and reports.
7. To coordinate with supporting departments i.e. QA, QC, Engineering & Maintenance, for achieving the day to day production targets and compliance.
8. To ensure facility is following EHS requirements.
9. Handling of Internal audits and external audits, and to coordinate for department audits.
10. Review of BMR and SOP.
11. To involve in media filling, qualifications and validations in coordination with cross functional teams.
12. To assist to production head and any new assessment shall be done as assigned by the production head.
13.To coordinate with supporting departments i.e. QA, QC, Engineering & Maintenance, for achieving the day to day production targets and compliance.
To ensure that the preventive maintenance, re-qualification of all the equipments done as per schedule.