Supervisor, Cleaning Validation

Date: Aug 18, 2019

Location: Etobicoke, ON, CA, M9W 6Y3

Company: Apotex

 

Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.

 

Job Summary

Responsible for supervision, training, and development of cleaning validation personnel involved in the preparation and execution of validation protocols, reports and qualification studies according to Good Manufacturing Practices and established Standard Operating Procedures. This includes responsibility for work scheduling and prioritization, as well as identifying and correcting potential roadblocks.

Job Responsibilities

  1. Responsible and accountable for competently supervising subordinates in accordance with the Occupational Health Act, Ontario, as well as Apotex’s Health and Safety policies and Safe Work Procedures (SWPs); provide all required training, equipment, tools and follow procedures in accordance with the Safety Charter; attend departmental audits and follow up on corrective actions within prescribed timelines.
  2. Oversee the daily operation of the cleaning validation group by:
    1. Ensuring that all protocols and reports are executed and approved in accordance with the department work schedule and guidelines
    2. Ensuring that all validation work is staffed and supported properly in order to ensure the customers deadlines are met
    3. Providing guidance and support for problem identification and resolution with protocols, reports or qualification studies
    4. Communicating and prioritizing projects with customers when conflicts or work scheduling issues arise
    5. Following up with the Manager to ensure all protocols and reports are reviewed in a timely manner.

 

  1. Ensure that all work is performed in full compliance with Good Manufacturing Practices, Standard Operating Procedures, established safety standards and regulatory requirements.

 

  1. Review CV documents and approve on behalf of the Manager as necessary.

 

  1. Review and assess impact of changes to the validation status, using the established change control procedures.

 

  1. Act as the main department liaison for the status of validation projects.

 

  1. Prepare and present monthly department measure reports for the department and

     Site Management.

 

  1. Review the department procedures and practices and optimize as required to ensure efficiency.

 

  1. In conjunction with the manager, ensure each role in the department has a training plan reflective of the job, and ensure both new and existing employees follow this training program.

 

  1. Take responsibility for the coaching and development of staff by ensuring each individual has a development plan.  Coordinate the training of new employees.

 

  1. In conjunction with the manager, conduct performance reviews of all direct reports.

 

  1. With support from the Manager and HR, perform any required disciplinary interviews.

 

  1. Participate in the personnel hiring process in conjunction with the Manager.

 

  1. Evaluate and approve vacation requests to ensure consistent service levels are maintained.

 

  1. Support direct reports in the creation and progression of personal development plans.

 

  1. Support the Manager during inspections by regulatory agencies.

 

  1. In conjunction with the manager, ensure that all department-specific costs are monitored and aligned to the budget.

 

  1. Facilitate Departmental meetings.

 

  1. Assume certain responsibilities of the Manager in their absence.
     
  2. Other duties as required.

Job Requirements

1.       Bachelor’s degree in Science or Engineering with 5+ years of pharmaceutical experience, preferably in validation.

2.       3-5 years of supervisory experience.

3.       Proven organizational, time management, and people management skills.

4.       Demonstrated experience in leading and motivating teams within a fast paced environment towards a common goal(s).

5.       Excellent oral and written communications.

6.       Strong interpersonal skills.

7.       Ability to work independently with minimal supervision.

8.       Strong customer service orientation.

9.       Experience in solid dosage and/or liquid dosage formulations, with an understanding of TPD, FDA, EU and other applicable regulatory guidelines is an asset.

10.    Working knowledge in the use of Microsoft office tools or similar software.  Familiarity with LabWare LIMS, SAP, and TrackWise is an asset.

 

 

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
 
Apotex offers 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.

 

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