Production Operations Support Manager

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.

For more information visit: www.apotex.com.

 

Job Summary

A role-holder to drive the production process (QMS-Investigation) to target the on-time Production and delivery of product with Quality & Compliance.

Job Responsibilities

1. To ensure that Current Good Manufacturing Practices (cGMP) are followed in area, as per cGMP regulations.

2. To ensure proper safety practices are in place and are followed, and also create awareness for same.

3. To identify the training needs of the team member as per the requirement and ensure the training is imparted on-time.

4. To ensure completeness of on the job training for team members in time, prior to perform any activity which is directly related to GMP

5. To ensure process of investigation is followed as per the SOP.

6. Collaborate with Subject Matter Experts (SMEs) and to perform a thorough and complete impact analysis

7. To ensure timely review of the investigation report and completion of Investigations and Deviations in QMS Track Wise.

8. To Investigate the Market complaints related to production and to ensure support for timely completion of Market Complaints providing manufacturing investigations.

9. To evaluate & find the root cause for any quality incident, Initiation of CAPA and ensuring the Implementation of CAPA till completion.

10. Recruit, train, develop and manage effectively the ongoing performance of his direct reports, which includes, but is not limited to:

    Ensuring their Job Descriptions are reviewed, signed and sent to Employee Services, annually,

    Reviewing and updating employee development plans, ensuring that all employees are properly trained and qualified to execute their duties.

11. Providing coaching, feedback and recognition.

12. Audit compliance monitoring (Internal, Corporate, Customer and Regulatory audit) for Production, WH and support Team.

13. Responsible to ensure compliance of team members (direct reports) with Safety and Employment policies (e.g., Respect in the Workplace-Prevention of Violence and/or Harassment).

14. Perform all work in support of our Corporate Values of Courage, Passion, Collaboration and Perseverance; Demonstrates strong and visible support of our values.

15. Performs all work in accordance with all established regulatory and compliance and safety requirements.

16. Participate and lead performance conversations with employees, including monthly one on ones, to correct on performance; check in on employee'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.

17. Utilize open, honest, two-way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.

18. Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values — Collaboration, Courage, Perseverance and Passion.

19. Utilize your networks to attract and hire talent in a comprehensive. differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.

20. Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.

21. To perform all other duties as assigned by superiors.

 

Job Requirements

• Education
  • B. Pharm

• Knowledge, Skills and Abilities
  • Adequate knowledge and ability in handling/ approving of deviations.
  • In depth knowledge of cGMP practices.

• Experience 
  • 17 years

 

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.

 

Experience Level

Mid Level