DGM – Production | Sun Pharma | Baska

Job Description

Roles and Responsibilities

• Overall in charge of Block D plant operations from material procurement to product dispatch along with operational activities, manufacturing actions, lean management, training, regulatory compliance, cross-functional coordination, new product projects, new CAPEX projects, safety, and administration.
• Monitoring of compliance to internal/ external audit as a requirement of current Good Manufacturing Practice, EHS, and local and international regulatory norms.
• To monitor departmental activities and ensure that all the department functions are in compliance and as per expectations of customers/businesses and various stakeholders.
• Coordinate external/ regulatory GMP audits at the plant and to ensure timely compliance of audit observations.
• Adherence and implementation of the company’s policy of GMP and assurance of quality.
• Risk assessment, process validation protocol, Incident and Investigation report, action, compliance, and closure. CAPA plans and closure, Protocols & reports. Internal Quality Audit / Regulatory Quality Audit Compliance and closure. Change control, Standard Operating Procedure, and Planned Modification. Other quality documents including amendments. To assure all-time readiness of the department for regulatory agency inspections/ internal audits and appropriate implementation of corrective actions regarding observations made by the agencies and internal audit team.
• Risk assessment, process validation protocol, Incident and Investigation report, action, compliance, and closure. CAPA plans and closure, Protocols & reports. Internal Quality Audit / Regulatory Quality Audit Compliance and closure. Change control, Standard Operating Procedure, and Planned Modification. Other quality documents including amendments. To assure the safety of patients, consumers, and people with a patient-centric focus.
• Leading for any inspection/audit of the department for regulatory agency inspections/ internal audits and appropriate support for smooth conduct of inspection, review, implementation of observations if any, and corrective actions regarding observations made by the agencies and internal audit team.
• Optimum utilization of man, material, and machinery of pharmaceutical products. Adequate resource availability with a focus on safety and quality first.
• Daily, monthly, and quarterly report analysis and short-term or long-term goal achievement.
• To ensure that products are produced and stored according to the appropriate safety, and cGMP requirements and to ensure the protection of the product from contamination and maintain quality as required.
• To ensure approval or rejection as per approved procedure and by authorized personnel.
• Supervised proper production planning, and planned execution of schedule as per work plan to meet the KPIs.
• Inventory control of raw materials/packaging materials/ engineering items/ miscellaneous and finished products including disposal of expired materials in coordination with the supply chain team.
• Responsible for the Destruction of the rejected products as per SOP.
• To work closely with the Environmental Health and Safety department to ensure all members of the organization are aware of safety policies to provide a safe workplace for employees.
• To ensure compliance with all EHS policies, laws, and regulations.
• To ensure statutory compliance for all matters of the plant. (e.g. Excise, various taxation authorities, pollution, electricity, safety, boiler, water regulation of the nation, and other applicable factory acts)
• Implementation of proper personnel policies of the company for conductive industrial relations cohesive working and team building.
• Participation in management reviews of process performance, product quality, and of the quality management system and advocating continual improvement
• To ensure lean management, operation excellence, GEMBA, yield improvement, waste reduction, etc. with an action plan and its implementation.
• Ensure that there are appropriate manufacturing and technical processes and procedures in place for the production.
• Ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality. The production records are evaluated and signed by a designated person. In coordination with the Quality head monitor the factor that may affect product Quality compliance of GMP and retention of records.
• To approve the instructions relating to production operations, including the in-process controls, and to ensure their strict implementation.
• Coordinate plant activities through planning with departmental leaders to ensure the total manufacturing objectives are accomplished in a timely and cost-effective manner and also meet customers’ expectations.

Desired Candidate Profile

Skills: Ophthalmic Production, Steril

B. Pharm / MS, M.Sc

18-25 Years of Relevant Experience.