Senior Manager, Production Operations Support

Job Summary

Responsible role-holder in production department responsible for planningexecution and co-ordination of manufacturing process related activity at LVMP GranulationCompressionEncapsulation and Coating sections.

Job Responsibilities

• Leading manufacturing department for planningexecutionreviewapproval and co-ordination of manufacturing process related activity at LVMP GranulationCompressionEncapsulation and Coating sections.
• To be involved in preparation of production schedule in coordination with SCM.
• Responsible for work allocation to deputy managersassistant managers and execution/adhereance of prdocution schedule.
• To coordinate with cross functions team and internal department team though daily DLM MeetingShift huddle meeting and other scheduled meetings on required basis
• To review and approval of Batch record (MMaR) Demo batch recordOptimization batch record placebo batchProcess validationCleaning ValidationProcess optimization batchDemo batch and other related protocol and report.
• Manage and execute QMS activities which includes preparationreview and approval like Change control deviation risk assessment CAPAtemporary change controlInternal audit report and responseVendor Audit report.
• Responsible for review and approval of above listed document using content serverPACEGLMS and Validator.
• Preparation review and approval of SOPsProtocols and Reports URS for new equipment/ instrument and involve in IQ OQ PQ of the equipment.
• To manage and execute continuous improvement in the manufacturing process equipment and instrument.
• To ensure department compliance in accordance with global and site SOPsregulatory requirement and CGMP standards.
• To act as an SME for manufacturing departmentinvolve in regulatory and internal audit and provide response to observations reported during audits.
• To be involved in recruiting process of new hire.
• To be involved in internal audit program and conduct internal audit for cross function department at ARPLAPIPL and vendor audit.
• To deliver training to production department as well as cross functional department.
• Participate and lead performance conversations with employees including monthly one on ones to connect on performance; check in on employeess progress toward achieving objectives offer support and remove barriers; and communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• Create a culture which values trust and provides the opportunities for employees development and growth in pursuit of our purpose and demonstrsting our core values.
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Develop strong working relationships with all levels to sustain a continuous improvement culture.
• To perform all other duties as assigned.

Job Requirements

• Education
  • Minimum degree in Skills and Abilities
    • Proficient knowledge of Good Manufacturing Practices (GMPs) & Good Documentation Practices.
    • Efficient communication strategic thinkingproblem solving skills and leadership quality.
    • Adequate knowledge to understand the written procedures and policies.
      
      
  • Experience
    • Minimum 10 years of experience in the production process