SDP HR Solution
Location
Ankleshwar | India
Job description
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
Technology Transfer,TT
Designation: Executive - Perform Program
Vacancies: 1
Experience: 0 - 3.0 Year(s)
Job tags
Salary
Rs 2 - 5 lakhs p.a.
