Senior Manager, Production Operations Support

Job Summary

Responsible role-holder in production department responsible for planning,execution and co-ordination of manufacturing process related activity at LVMP Granulation,Compression,Encapsulation and Coating sections.

Job Responsibilities

• Leading manufacturing department for planning,execution,review,approval and co-ordination of manufacturing process related activity at LVMP Granulation,Compression,Encapsulation and Coating sections.
• To be involved in preparation of production schedule in coordination with SCM.
• Responsible for work allocation to deputy managers,assistant managers and execution/adhereance of prdocution schedule.
• To coordinate with cross functions team and internal department team though daily DLM Meeting,Shift huddle meeting and other scheduled meetings on required basis
• To review and approval of Batch record (MMaR), Demo batch record,Optimization batch record, placebo batch,Process validation,Cleaning Validation,Process optimization batch,Demo batch and other related protocol and report.
• Manage and execute QMS activities which includes preparation,review and approval like Change control, deviation, risk assessment, CAPA,temporary change control,Internal audit report and response,Vendor Audit report.
• Responsible for review and approval of above listed document using content server,PACE,GLMS and Validator.
• Preparation, review and approval of SOPs,Protocols 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 SOPs,regulatory requirement and CGMP standards.
• To act as an SME for manufacturing department,involve 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 ARPL,APIPL 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 employees’s 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 B.Pharm/M.Pharm
    
    
• Knowledge, Skills and Abilities
  • Proficient knowledge of Good Manufacturing Practices (GMPs) & Good Documentation Practices.
  • Efficient communication, strategic thinking,problem solving skills and leadership quality.
  • Adequate knowledge to understand the written procedures and policies.
    
    
• Experience
  • Minimum 10 years of experience in the production process