Head of Engineering (API)

Biocon; Visakhapatnam; On-site; INR 8,00,000 - 12,00,000; Full time

Job summary

A leading biopharmaceutical company in India is looking for a qualified individual to oversee costing, budgeting, and legal compliance within their department. The successful candidate will interact with regulatory authorities, manage audits, and implement GMP regulations. Responsibilities include inventory management, project management, and ensuring a safe working environment. Ideal candidates will have strong decision-making skills and be proficient in quality management systems.

Responsibilities

• Costing and budgeting for the department.
• Ensure all legal requirements are met and take action on discrepancies.
• Interact with regulatory authorities regarding legal matters.
• Coordinate internal and external audits related to QMS and EHS management.
• Ensure audit findings are closed on time.
• Manage non-conforming products and implement corrective actions.
• Documentation and data control.
• Implement GMP regulations.
• Implement energy conservation measures.
• Identify training needs within the department.
• Ensure a safe working environment.
• Manage inventory.
• Ensure equipment is operated and maintained as per recommendations.
• Set objectives for personnel.
• Delegate roles and responsibilities.
• Decide on operational changes and procedures.
• Authorize legal documents.
• Review deviation reports and change controls.
• Manage projects from planning to execution.
• Approve commercial documents.
• Evaluate training of personnel.
• Approve specific equipment for use.
• Approve routine activities in SAP.

Job description

• Costing and Budgeting for the department.
• To ensure all the legal requirements are met and initiate suitable action in the event of discrepancy noted, if any.
• Interact with regulatory authorities with matters concerning the legal requirements.
• Co-ordination for audits (Internal and external) related to QMS and EHS management system.
• Ensure all the audit findings are closed within the stipulated time.
• Non-conforming products and corrective actions - implementation as suggested by Quality Assurance.
• Documentation and data control.
• Implementation of GMP regulations.
• Implementation of energy conservation measures.
• Identification of training needs in the department.
• Ensure safe working environment for the employees.
• Inventory management.
• Ensure all equipment's are operated and maintained as per manufacturer's recommendation.
• Set up objectives and targets for the personnel.
• Delegate the roles and responsibilities in the department.
• Take decisions on changing the operations and working procedures.
• To authorize legal documents.
• Authorizing of equipment qualification.
• Preparation and reviewing documents / records related to QMS and EMS under SMV facility.
• Authorized to review the deviation reports, deviation requests and change controls.
• Project management which includes planning, execution, monitoring & closure.
• Approval of commercial documents.
• Training evaluation of the personnel.
• Approval of specific equipment for use.
• Approval of routine activities in SAP.