Eisai Pharmatechnology & Manufacturing Private Limited operates as a manufacturer of pharmaceutical ingredients and formulations. The company was founded in 2007 and is based in Visakhapatnam, India. Eisai Pharmatechnology & Manufacturing Private Limited operates as a subsidiary of Eisai Co. Ltd.
Post: Project Manager-Production/Manufacturing/Maintenance
Job Description:
Responsibilities
• Ensure the systems, procedures and practices are followed for smooth start-up of API operations and execution of API Production Plan.
• Assist in Preparation and approval of all Standard Operating Procedures (SOP), Work Instructions (WI), and manufacturing batch records for API manufacturing.
• Assist in timely installation, commissioning and validation of all the API equipments in the Plant.
• Ensures timely execution of Pre-validation and Validation batches and co-ordinates effectively with the Project team for the technology transfer of Products from Japan.
• Ensures all completed Manufacturing batch records are reviewed in time,for completeness and compliance with cGMP requirements and regulatory requirements.
• Ensuring all on-line documents are maintained well.
• Performs managerial duties including Production Plan scheduling, execution, prioritizing, training, timecard review, performance evaluation, and disciplinary action.
• Ensure optimum inventory levels for achieving cost savings without hampering the production process and preparing reports for the same.
• Meeting all the delivery schedules for the products as committed in the Plan. Co-ordination with API Research team, Quality Assurance, Quality Control, Engineering and Warehouse functions to ensure compliance to the committed Plan.
• Maintaining and up keeping the area as per the cGMP and Regulatory requirements and putting continuous efforts for improvement in quality and Productivity.
• Handling manpower, resolving issues, team building, training and development of Operating personnel and subordinates.
• Reviewing day to day activities at start of the day and pass on instructions.
• Cooperation during audits.
Candidate Profile:
Requirements:
Educational Qualifications:
• Graduate/Post Graduate degree in Chemistry, Pharmaceutical chemistry, Pharmaceutical Engineering, Chemical Engineering with 8+ years of experience in Manufacturing of APIs.
• 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.
• Excellent written, oral, communication and organizational skills, leadership, training and interpersonal skills are necessary.
Additional Information:
Experience: 8-12 years
Location: Visakhapatnam
Education: B.Sc-Chemistry, M.Sc-Chemistry
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Production
End Date: 20th June, 2011
Apply/Send resume at, epm-career@epm.eisai.co.in
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