Team Leader - Production

.1 Adhere to Organization Safety/Quality policies, Procedures and norms effective from time to time.

1.2 To ensure effective implementation of company policies and procedures in operation unit.

1.3 To implement cGMP Practices in all areas and operations are carried out as per cGMP regulations and ensure the all-time compliance for regulatory requirements.

1.4 To ensure that the appropriate qualifications, validations, calibrations, preventive maintenance are done as per requirement and to review validation, qualification documents and all related reports.

1.5 Participation in the investigation for incident, OOS, OOT, Batch failures, Market complaints and product recalls.

1.6 To review of SOPs, BMR/BPR and all other GMP records as per requirements.

1.7 To review/approve related quality notifications (CRN/Incidents/CAPA) Quality risk management exercise and QMS documents and closure of the same.

1.8 To participate in GMP/Regulatory Inspections (Internal/External) its compliance.

1.9 To drive continuous improvement within the scope of the operations and strengthening the existing foundation through LDM.

1.10 Ensure the adherence of SHE standards and policies across the plant with respect to MSI

1.11 Annual performance evaluation of sub-ordinates.

1.12 Preparation and tracking and cost saving policies to reduce of OPEX budget for the plant.

1.13 Build organization and people capability to ensure right first time and Zero Incidents.

1.14 Autonomous Capabilities, Culture and way of working.

1.15 Most efficient sterile plant in industry on people, cost and service.

1.16 A culture of Waste elimination and continuous improvement from Day 01.

1.17 Meet timelines on new product filings and time to market.

1.18 To ensure the yield of the product at respective stage of batch processing is within the specified limit.

1.19 To ensure the procurement of spares/consumables/necessary resources for the respective equipment/instrument maintenance through SAP.

1.20 Responsible for handling of SAP,FIORI and DOCHUB applications,

1.21 To perform any other task/project assigned by production head from time to time.

B. Tech

Team Coaching, team handling, team managementvalidation Qualification audit and compliance, production planning, resource planning, capacity planning, troubleshooting,