Senior Coordinator - Quality Assurance Contract

Job purpose

The main responsibility for this position is to update various TARO document types to meet SUN's

rebranding requirements.

Duties and responsibilities

• Initiate a Project Plan for update of “Taro” documents according to new SUN's guidelines (replacement of logo, related content, format, etc.)  under Management guidance.
• Prepare and revise documents in accordance with an organized project plan, and with pre-determined target dates as per GMP guidelines.
• Responsible for obtaining signatures for review and approval in the document revision cycle.
• Verify and submit documents to the appropriate roles/functions and upload approved documents in the respective Quality Systems folders or directories.
• Process documents using simple workflow where editorial corrections are required, such as a logo or format change only, and using complex workflow where “Taro” content has to be updated.
• Liaise with QA Documentation team members and Manager, QA Documentation/Change Control with respect to Document workflow as required.
• Manage tasks and activities for Documentation Change Control records within the Trackwise System.
• Provide leadership and support to Department stakeholders in the Re-branding Project activities.
• Any other duties related to Re-branding Project and Documentation as required.

Additional responsibility (Only applicable to customer facing roles)

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

• Bachelor’s Degree in Science, or other related discipline preferred
• Previous Quality Assurance experience (2-3 years) in the pharmaceutical Industry is an asset.
• Well-developed interpersonal and teamwork skills
• Ability to establish and prioritize daily work schedules in a fast-paced environment.
• Proficiency in MS Office -Word, Excel, and PowerPoint.
• Ability to work independently.
• Knowledge of Health Canada and FDA regulations
• Good communication and time-management skills
• Strong organizational skills and ability to multi-task; detail-oriented.
• Personable, and able to maintain excellent relations with internal clients
• Any deviations to procedures or systems are brought to the attention of management.

Working conditions

• Numerous and varied responsibilities demanding attention and detail
• Working in general office environment.

Physical requirements

Office based

Direct reports

NA