The Opportunity

This role provides direction to the Manufacturing and Finishing Operations team at the Korangi Plant in Karachi. Reporting to the Operations Director, this position is responsible for ensuring compliance with local Regulatory requirements, cGMP, EHS & and Abbott Quality standards during manufacturing and finishing operations.

Core Job Responsibilities

Prepare and Monitor Operational Plan for Optimum utilization of Resources i.e. Material, Labour & OverheadsEnsure that products are manufactured under conditions that meet Abbott Policies, EHS Standards, and Regulatory and cGMP requirements.                    Ensure compliance with labor laws, security standing orders & code of Business conduct.Ensure provision of the necessary resources (area, equipment, workforce, etc.) to produce products of the required quality.Ensure that required initial and continuing training of production personnel including GMP training is carried out and adapted according to need.Provide strategic direction in Mfg. technology and equipment. Ensure that maintenance of premises and equipment, calibrations, and Process Validation are performed and recorded.Coordinate with Quality regarding QA Audits, CAPA, Complaints, ERs, Market Returns, and Trend Analysis Reports, etc.Coordinate with QA, Regulatory, Technical Centre, Engineering, and Supply Chain in the resolution of quality problems, disposition of nonconforming issues, and ensure uninterrupted product deliveries to Commercial.Prepare Plant annual budget in consultation with Finance and get it approved by Management.Take into account all demands, including forecasts, contracts, customer orders, samples, special prototypes, spares, interplant, etc in creating a Master Schedule that directs and drives all manufacturing, purchasing, and manufacturing-related engineering activities.Monitor KPIs and perform Root Cause Analysis where applicable. Review and approve technical documents including SOPs, Manufacturing and Finishing Directions including in-process controls, Shop Orders, Validation documents, Change requests, CAPA and ERs, etc. Ensure that the production records are re-evaluated and signed by a designated person before they are made available to the Quality Assurance department. Review new product dossiers and Manufacturing input for preparation of product registration / re-registration and their submission to the Regulatory Department. Review batch variance/yield reports with production managers and take appropriate steps for improvement. Expose, prioritize, and stimulate the reduction or elimination of non-value-added activities. Ensure employee development, Goal Setting, Performance Assessment, and succession planning within the department.  Any other task assigned by Director Operations.

Qualifications

B.Pharm/Pharm.D 10 years of working experience in Manufacturing and Finishing operationsKnowledge of Drug Rules, cGMP requirements, and Quality StandardsUnderstanding of Supply Chain Management of Multi-National Companies                   Awareness of Operational Finance and Capital BudgetingUnderstanding of Business Excellence (CI) and New Product Development activities

Competencies required:

Good communication and Interpersonal skillsProven Leadership qualitiesAbility to thrive in a fast-paced environment