- Improve efficacy in productivity at plant.
- Ensure that all Drawings/ Layout are available with site contractors and construction team for execution.
- Ensure all execution activities are conducted as per Approved Drawing and Layout.
- Co-ordinate with Inter Departmental Persons about finalization and procurement of equipment's and instrument.
- Approval of Indent and Purchase Order raised by concerned Departments.
- To carry out the FAT at vendor side with inter Departmental Persons.
- Provide Approval/ Authorization for dispatch of equipment instrument from Vendor.
- To ensure and assist the team for correct installation of New Equipment / Instrument and monitor there qualification and calibration activity.
- Recruitment of qualified and skilled manpower and ensure appropriate Training.
- To assist the team regarding execution of jobs and all plant related activity as per the cGMP and Regulatory Agencies.
- Authorization of Quality Manual.
- Authorization of Site Master File.
- Authorization for Validation Master Plan and Validation Procedure.
- Improvement, Periodic Review and updation of current SOP and Quality System.
- Review of Department Standard Operating Procedure for Oral Dosage Facility.
- Conduct Self Inspection and assign the Corrective and Preventive Action
- Maintain MIS of site progress on monthly basis.
- Ensure that Safety and Quality Controls are well established and monitored on Periodic Basis.
- To coordinate with self-inspection team for improve the Quality System.
- Attend to all Customer/ Regulatory audit and compliance to audit observation.
- Review of Change Control.
- Review of Deviations.
- To become an active participant in the Investigation to find out root cause and corrective and Preventive Action.
- Review of Out Of Specification (OOS) Investigation.
- Under take customer complaint Investigation and Approval of Investigation Report.
- Liasoning with Food & Drug Administration in India.
- To co-ordinate for product recall and approval of report.
- Responsible for setting and achieving quality and compliance objective and adhering to budgets.
- Organize and co-ordinated requirements of business team.
- Providing regular updates to senior team as well as updating monthly reporting and other tracking database.
- Ensuring that safety precautions are followed at work place.
- Maintain discipline in plant.
- Organize the daily operation of manufacturing plant.
- Represent in a Team of Quality Management Review. )
Harman Finochem - Aurangabad, India - Harman Finochem Ltd
Description
Site Head (Formulation Oral Solid Dosage) at Harman Finochem Limited - 25+ years company - Harman Finochem Limited is an India-based Pharmaceutical Company catering to its clients across the globe.
Bhupinder Singh Manhas in 1983, our core competencies are in manufacturing and exporting of Active Pharmaceutical Ingredients mainly Metformin HCl, Fenofibrate, Divalproex Sodium, Riboflavin Phosphate Sodium, Glycopyrrolate/Glycopyrronium bromide and more.
Website - of Exp years in solid oralsLocation - Aurangabad, Maharashtra
Qualification required - B.pharma / M.pharma
Job Responsibilities -•Administration activity related to plant operations.
Authorization of following Qualification/ Validation Documents:
10.1. User Requirement Specifications
10.2. Design Qualification
10.3. Installation Qualification
10.4. Operation Qualification
10.5. Performance Qualification
10.6. Process validation
10.7. Cleaning validation
10.8. Computer validation
10.9. Re - Validation