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Job Information

    • December-19-13
    • Full Time
    • Management
    • 3 Years
    • Pharmaceutical

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Manager, QAIP Manufacturing

APOTEX INC.

Richmond Hill, ON, CANADA
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About Apotex:

 

Apotex is the largest Canadian owned pharmaceutical company, and the largest producer of generic medicines in the Country. We have an incredible team of bright, passionate, and committed individuals who are proudly dedicated to our mission of bringing a growing array of high quality, affordable medicines to the healthcare systems in 115 countries around the globe. We are looking for the cream of the crop to join our team!


We offer competitive pay, exceptional career development, state-of-the-art facilities, and the opportunity to work with leaders in the field. But we also offer something more… the satisfaction that comes from knowing that the “product” we produce will improve the quality of human lives, and in some cases, save them. Our products, most importantly, are also accessible by people from all economic backgrounds.

 
We’d love to hear how you could contribute to the team!

 

 

Job Summary:

 

Responsible for developing and maintaining a focussed team skilled and trained to support the Quality Assurance and business needs of the organization. Ensures that GMP and QAIP activities are conducted in accordance with current regulatory requirements. 
Coordinate on the floor release activity along with Supply Planning to meet business and sale requirements. 
Establish  Metric to measure the effectiveness of the system. Provides guidance, technical support and direction for troubleshooting to manufacturing and packaging operations.

 

 

 

Job Responsibilities:


Manages on-going QA In process activities including testing and release of bulk product for Packaging. Manages IPC activities to be performed during filling operations:
• Interacts with the Production group to determine bulk product for release.  
• Mentoring of staff to ensure PAID values are followed at floor level.
• Ensures alignment of QAIP activities with Production Group.
• Be a leader in resolving issues which otherwise would delay the release of product.
• Supports Supply Groups with launch activity to ensure timely resolution of issues in order to meet business deadlines. 
• Supports AD of Sterility Assurance with audits, observations and ongoing projects related to the Quality function of the business

 

Develops and executes plans to enable the QA In Process team to meet the long-term compliance and business goals and objectives of the company:
• In conjunction with AD of Sterility Assurance, conducts appropriate resource-planning analysis and submits forecasts for headcount, capital and expense budget.
• Works with the Human Resources group to recruit and hire for open and approved new positions.
• Manages expenses to budget targets.  Provides justification for significant expense over or under budget

 

Provides support for new product launches:
• Support launch activities through review/approvals of Change Controls for internal and external products.
• Provides support through review and approval of Investigations in Trackwise for internal and external products.
• Participate as required in product launch or high priority failure investigations for both internal and external products

 

Maintains current knowledge of manufacturing GMP issues and reviews and revises processes to optimize compliance and efficiency:
• Develops and maintains thorough knowledge of Canadian and international GMP requirements as they relate to the manufacturing of pharmaceutical products specifically and pharmaceutical production in general. 
• Ensures Bulk Product Release and IPC’s reflect current GMP requirements that best support the business.  
• Evaluates proposed changes to or new processes from other areas in which Product Release is a stakeholder for compliance and regulatory requirements. 


Challenges and changes existing processes to make the most effective use of QA In Process resources:
• Ensures, when required, operating procedures are modified promptly and timely training of impacted individuals occurs.
• With AD of Sterility Assurance, develops, maintains and publishes performance measures

 

Employee Performance, Development and Administration:
• Defines activities and responsibilities for each role in a current accountability statement.
• Provides a written training curriculum for each staff member to support the accountability statement.  
• Ensures each staff member understands the training requirements for their role and is compliant to curriculum for tasks performed.
• Ensures ongoing and timely performance feedback for all reports. 
• Produces objective, supportable, written performance reviews for direct reports and ensures production for indirect reports.  
• Clearly communicates performance expectations as part of the review process. 
• Manages performance issue resolution through the compatibility process.
• Ensure that career development dialogs occur with all reports and are documented as part of the annual performance review process.
• Manages employee absence (vacation, illness, leaves, lateness) and personnel changes in line with employee entitlement and company policy.

 

 

Job Requirements:

 

• Bachelors degree in science 
• Five years of quality assurance experience in the pharmaceutical industry.
• Three years of supervisory experience preferably in a quality role.

• Must have sterile experience.
• Excellent ability to delegate and can effect change through others without direct involvement
• Exercises innovative tactics and encourages others to demonstrate creative approaches
• Strong organizational, interpersonal, written and communication skills.
• Proven ability to lead and motivate subordinates.
• Strong understanding of GMP requirements and their application in a manufacturing environment.
• Knowledge of international GMP requirements, especially FDA and EC, 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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