Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, iversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company now employs approximately 70,000 people and markets its products in 130 countries worldwide.
Post : Assistant Manager Production
Job Description
Active participation in procurement of manufacturing equipment, instrument, tooling’s and other miscellaneous items in coordination with CFTs & vendors. Ensure for installation and commissioning of the new manufacturing equipment's. Plan & Execute the trial of the manufacturing equipment with other CFTs and evaluate the results. Ensure that the appropriate qualification and validations (Equipment, Process and Utilities) are carried out in the Granulation, Compression and packing area. Co-ordination with other support function for effective implementation of action item identified. Handling of change control and preparation of required documents for change control. Impart training to operators & workman on shop floor for GxP activities. New SOP preparation, review and gap identification as per guideline and Abbott Quality system requirements. Prepare short term plan for to ensure achievement of budgeted volumes and timely deliverance of product with quality. To Prepare plan for man and equipment management. People management (responsibility for leading, motivating, training and developing the subordinates).
Ensure compliance of all procedures, practices, and system to cGMP with respect to WHO guidelines, Abbott Quality guidelines, other applicable regulatory guidelines and Standard Operating procedures at site. Ensure that Good Documentation practices shall be comply during production process. Internal and External co-ordination such as Planning and Control, QA, TechOps, Engineering, HR Department, I&D etc. Decision making. Operational - Tracking, monitoring and closure of action plan and CAPA. Mitigation plan if required during operation. Any other activities/support as instructed by the superiors as and when required.
Ensure that current Good Manufacturing Practices and Good Documentation practices shall be implemented. Provide support and guidance to improve the right first time of the production batch / batch documents. Preparation, review of protocol and report (Technical / Study / Non-routine ) on need basis. Responsible for investigation of exception / non-compliance in the production area, preparation and review of investigation report. Review of standard operating procedure, master documents of production and batch documents, etc.
Candidate Profile
B.Pharm / M.Pharm with 8-12 years of experience in core manufacturing / at the shop floor operations of pharmaceutical company. Candidate should have approved chemist license Should have expertise in Granulation, Compression & packing Department in a OSD facility. Should have exposure in machine installation & qualification activity. Well versed with CAPA, GMP Documentation, should have exposure to regulatory audits such as MHRA, USFDA etc.
Additional Information
Experience : 8-12 years
Qualification : B.Pharm / M.Pharm
Location : Baddi
Industry Type : Pharma
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