Title:  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