Executive - Perform Program

Contribution in management and control of both site project/transfer as well as donor Documentation, such as Product transfer protocols, product transfer checklist, associated BMRs, Master Documents, etc.

• Preparing & review of the Product Transfer Documents, i.e. Product Transfer checklist Product transfer protocol and Report

• Preparation and Review of Batch Manufacturing Records

• Preparation and Review of protocols for validation/verification of product / process

• Preparation, Review and certification of validation/verification reports after execution

• Coordination with operations as well as other cross functional team for project activity including execution the identified projects

• Ensure adherence to company Quality Standards, Local FDA MHRA regulations, by Understanding the requirements

• Performing the Gap analysis to find out the gaps in existing system

• Preparing and sustaining a project plan for timely implementation

• Contribute to the identification and implementation of best practice, policies, processes and procedures to aid and improve operational performance.

• Support continuous improvement through cost engineering techniques and operational excellence techniques, identifying inefficiencies and cost optimisation opportunities

• Identify and quantify all type of waste versus standard of the current products

• Analyse and identify key areas of improvement for operational processes and efficiency on production lines

Reporting

• Monitor the overall tracking of project/optimization/launch and operational improvement initiatives that deliver the expected results

• Monthly Reporting driven by KPIs dashboard

• Opex budget preparation and reporting for transfer and development projects.

• Monitor and review data and information to detect and assess problems and make recommendations to resolve issues

• Ensure appropriate monitoring, reporting systems and procedures are in place to meet objectives

• Provide strategic and operational information and reports to share with others when required

• Report on achievement of targets and identify any actions required

Skills Required

• Project Management

• Knowledge of GMP and regulatory requirements

• Knowledge of OSD formulation process and associated documentation, validation / verification

• Good interpersonal skills and computer operating skills

• Believes and lives in company values

• Skilled in team work

• Must be able to present complicated technical issues in an easy and understandable manner and obtain appropriate actions

• Must have global view, able to understand the impact of the decision on other company functions.

• Understands Global organization and related processes

Education and Experience

• Graduate / Post Graduate in Pharmacy

• 03-05 years in Pharma industry with awareness of Quality management systems, Project Management, manufacturing activities, process validation and EU Regulatory requirements