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Position: Manager – Production
Location: Vil. Mauza, Baddi, Himachal Pradesh, India
- Ensure that current Good Manufacturing Practices and Good Documentation practices shall comply at Granulation & Compression.
- Responsible for investigation of exception / non-compliance in the production area, preparation, and review of the investigation report.
- Implementation of Quality Management System as per cGMP and international requirement at Granulation & Compression.
- To perform root cause analysis for the exception / non-compliance.
- The person shall be responsible for product line clearance, Machine operation & cleaning, batch reconciliation.
- Perform the GEMBA with a cross-functional team including Quality Assurance, Engineering, Warehouse, and Quality Control, etc. to investigate the exception / non-compliance.
- Preparation and review of CAPA report (Corrective Action and Preventive Action) and follow up for implementation.
- Provide support and guidance to improve the right first time of the production batch/batch documents.
- Handling of change control and preparation of required documents for change control.
- Impart training to a workman on the shop floor for GxP activities.
- SOP preparation, review, and gap identification as per guidelines and Abbott Quality system requirements.
- Preparation, review of protocol and report (Technical / Study / Non-routine / Reprocessing / Repacking) on need basis.
- Audit preparation and compliance for the audit observation.
- Prepare a short term plan to ensure achievement of budgeted volumes and timely deliverance of product with quality.
- Prepare a plan for man and equipment management.
- People management (responsibility for leading, motivating, training and developing the subordinates).
- Ensure that initial and continuing training of department personnel is carried out and adapted according to need.
- Ensure that the appropriate qualification and validations (Equipment, Process, and Utilities ) are carried out in the Granulation and Compression area.
- Co-ordination with other support functions for effective implementation of action item identified.
- Identify the training needs of the team and ensure fulfillment.
- Ensure compliance of all procedures, practices, and systems to cGMP with respect to Schedule M, WHO guidelines, Abbott Quality guidelines, other applicable regulatory guidelines, and Standard Operating procedures at the site.
- Ensure that Good Documentation practices shall comply during the production process.
- Internal and External coordination such as Production, Planning and Control, QA, TechOps, Engineering, HR Department, I&D, etc.
- Decision making. Operational – Tracking, monitoring, and closure of action plan and CAPA.
- A mitigation plan is required during operation.
- Any other activities/support as instructed by the superiors as and when required.
- In absence of the position holder, the subordinate Executive / Manager working in the section or authorized designee (as applicable) shall be responsible for day to day working.
Desired Candidate Profile:
- Incumbent having experience in core manufacturing / at the shop floor operations of pharmaceutical company
- Should have expertise in Granulation & Compression Department
- Well versed with CAPA, GMP Documentation, QMS
- Should have exposure to regulatory audits such as MHRA, USFDA, etc.
Qualification: B.Pharma, M.Pharma
Experience: 10-15 Year
Work Location: Village Mauza: Baddi
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