Senior Manager, Production Operations Support

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

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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.

• 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.

• 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

At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. 

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.