Specialist, Change Control

3 weeks ago

Brampton, Canada Taro Pharmaceuticals INC, Canada Full time

**Taro Pharmaceuticals Inc.** is a multinational, specialty pharmaceutical company with a vision of reaching people and touching lives globally as a leading provider of valued medicines. We are dedicated to meeting the needs of our customers and the overall community through the innovation, development, manufacturing and marketing of the highest quality healthcare products.

Established in 1950, Taro’s world class production facility is located in Brampton, Ontario, with a current team of over 600 Canadian employees. Our company’s focus on the dermatology sector has made us a leading manufacturer and supplier of specialized topical products with a diverse portfolio of creams, ointments, liquids, and gels.

With support from our parent company, Sun Pharma, one of the world’s largest specialty generic pharmaceutical companies, we are committed to providing a healthy, safe and rewarding environment for all of our employees.

**What we offer**:
A safe and clean; GMP regulated work environment

Opportunities for career growth and development

A competitive wage/salary

Incentive bonus programs that are designed to reward employees for their individual contributions

Benefit programs designed to support our employees and their families, including a comprehensive health & dental benefits package, group RRSP matching program, direct access to healthcare and well-being programs, and paid time off

Employee training and organizational development programs including tuition reimbursement, internal mobility programs, and employee recognition programs

**General Summary**:
This role will be responsible for all change control activities in procurement department.
- Review all type of change notification from the suppliers for raw materials,

Active Pharmaceutical Ingredient (API), components for commercial and R&D.
- Facilitate the procurement team with Change control creation and timely closure.
- Manage activities of all change controls, investigations and CAPAs for Supply Chain.

**Principal Duties and Responsibilities**:

- Responsible for initiating change control for introduction of new suppliers.
- Responsible for change controls for alternate source of material.
- Create the change control for all type of change notification from supplier.
- Responsible for managing CAPA’s and investigations for Supply chain.
- Meet with stakeholders and explain the reason of change and get their input.
- Assess the regulatory requirement and impact for any kind of change.
- Coordinate with QA, QC, Pharmatech, Validation, Stability, Compliance and other department for their inputs and suggestions in change control.
- Ensure that the impact of the proposed changes are accurately interpreted into change control.
- Monitor open change control proposals and close in timely manner with all task completion.
- Follow-up with stake holders to complete the outstanding tasks before due date.
- Keep track of all open change notification and ensure to create the CC on timely manner.
- Work with Procurement team to ensure all Change Control are completed or initiated.
- Create the proper change control extension form and approve for desired change control.
- Review activities performed for change controls to ensure completeness of the package prior to closure of the change.
- Prepare the monthly report of change control processed and closed.
- Additional duties as assigned.

**Knowledge, Skills and Abilities**:

- Ability to influence others to do things while maintaining integrity and trust, by keeping a continuous focus on effective communications to ensure achievement of shared goals.
- Excellent written communication and report writing skills.
- Strong organizational skills and ability to multi-task; detail oriented.

**Background and Experience**:

- Minimum of 3-5 years of experience in quality systems.
- University or college degree or certificate in quality management system
- Knowledge of Health Canada, FDA regulations and ISO requirements.
- Ability to work with little or no supervision and track multiple processes.
- Outstanding organizational and coordination abilities.
- Quick critical thinking and problem-solving abilities
- Good collaboration and team work abilities
- Ability to work in a fast-paced environment
- Advanced data analysis and data visualization.

**Problem Solving**:

- Process improvement mindset with ability to enhance productivity and reduce non-value added work.
- Able to work with IT department to create logical reports
- Attention to detail

**Working Conditions**:

- General conditions include office and warehouse work
- Mix of standing, walking, and desk work
- Clean environment
- Ability to work in a fast pace environment and ability to prioritize workload

**Working Conditions**:
The role requires flexibility regarding work hours (including off normal business hours) in the event of system breakdown. The Purified Water Systems are critical to business operations and any downtime in operations has

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