Date PostedNovember 4, 2022
Location (State / UT)
Experience18 Years, 25 Years +
Desired QualificationBachelor Degree, Master’s Degree
This role will be overall in charge of block 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 ensures timely compliance with 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, Planned Modification. Other quality documents include 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.
- 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.
- Ensure that products are produced and stored according to the appropriate safety, and cGMP requirements to ensure the protection of the product from contamination, and maintain quality as required.
- 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.