Company based in Tokyo, Japan is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Company corporate human health care (hhc) mission is to give first thought to patients and their families, and to increase the benefits that health care provides. Pharmatechnology and Manufacturing Pvt. Ltd, a subsidiary of Co. Ltd is setting up a state of art Research and Manufacturing facility for Active Ingredients and Formulations at Visakhapatnam, AP for export to global pharmaceutical markets.
Post: Manager-API Process Engineering function
Job Description:
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Performs Managerial duties including Production Plan scheduling, execution, prioritizing, procurement, hiring, training, timecard review, performance evaluation, and disciplinary action.
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Meeting all the delivery schedules for the products as committed in the Plan.
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Co-ordination with API Research team for Scale up projects from Kilo Lab to Pilot Plant and ensuring the deliveries as per requirements.
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Process Improvement to optimize the process timing and cost.
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Co-ordination with Quality Assurance, Quality Control, Engineering and Warehouse functions to ensure compliance to the committed Plan.
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Ensures all completed Manufacturing batch records and Packaging batch records are reviewed for completeness and compliance with cGMP requirements and regulatory requirements
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Creates departmental budget and maintains budget conformance. Optimum utilization of funds by avoiding unnecessary and avoidable expenses.
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Ensure optimum inventory levels for achieving cost savings without hampering the production process and preparing reports for the same.
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Maintaining and up keeping the area as per the cGMP and Regulatory requirements and putting continuous efforts for improvement in quality and Productivity.
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Handling manpower, resolving issues, team building, training and development of Operating personnel and subordinates.
Candidate Profile:
Chemical Engineer with 10+ years of experience in Manufacturing of APIs.
Knowledge of Process Engineering function.
Strong understanding of API manufacturing operations. Demonstrate knowledge of GXPs, ICH, and other regulatory guidelines for manufacturing of APIs.
Good organizational skills, planning and the ability to multitask is a plus and experience in working with diverse cultures in a dynamic, fast-paced environment.
Extensive experience in manpower handling, team building and resolving shop floor issues arising out of personnel inefficiencies or technical incompetence.
Demonstrate strong knowledge of regulatory guidelines for US FDA, MHRA, TGA, MCC, etc and Industry knowledge.
Proven ability to work independently and in a team environment.
Strong working knowledge of Word, Excel, PowerPoint and SAP system.
Excellent written, oral, communication and organizational skills, leadership, training and interpersonal skills are necessary.
Additional Information:
Location: Visakhapatnam, A.P.
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Other
End Date: 17th Jan, 2013
Contact Details:
Malathi Anupoju
malathi.a@alpconsulting.in
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