1. Responsible & accountable as a lead for compliance.
2. To review and approval of all master document like standard operating procedures, batch manufacturing, incidents/events, process validation, annual product reviews, master datas, protocols and qualification documents.
3. To review the Production planning, weekly / monthly / yearly as per the forecast /market requirement and complete within timelines.
4. Utilization of resources as per the work demand and target timelines.
5. Effective coordination with CFT teams for smooth flow of Manufacturing and Packaging activities.
6. Responsible for QMS compliance & investigation of event , market complaint & effective CAPA closer.
7. Responsible for change control approval, execution and closure cycle.
8. Provide motivation, support and guidance to the team to build a quality working culture.
Job Description
Safety:
To ensure 100% secure operation in production area.
Ensure all the necessary PPE’s are available in production facility and monitor proper PPE’s are worn by the personnel’s during operation. Reporting the near misses and ensure their compliance. To follow the procedure pertaining to the environmental management system (ISO14001 & ISO45001). To support in implementation new procedure related to environment management system. To follow and maintain 5S in workplace.
Quality and Compliance:
No Critical/Major observations in GMP regulatory audit i.e. internal/external. cGMP compliance in entire manufacturing and packaging area and SOP compliance on all aspects. Upgradation of system consistently to deliver the quality production, improvement to plan. Ensure all area logbooks, BMR entries and all documents calibration records area online and updated. Area up keeping hygiene, cleanliness, all areas are in good condition for 24x7. Ensure proper people, material, scrap, SFG movement to avoid cross contamination. Ensure proper Status labeling of each area, item, equipment, accessories, and sc