Qms and Documentation Specialist

1 week ago

Montréal QC, Canada Medisca Pharmaceutique Inc Full time

**Medisca** is a global corporation with locations throughout North America, Australia, and Europe, that contributes to healthcare by leveraging strong partnerships that deliver customized solutions with an unwavering commitment to quality and innovation. Backed by 30+ years and a strong foundation in pharmaceutical compounding, **Medisca** is a business-to-business company that delivers comprehensive offerings by providing value, consistency, responsiveness, and loyalty. From pharmaceutical compounding products and services, to supply chain solutions, mixing technology manufacturing, analytical testing, IP licensing, to education services and more - **Medisca** delivers extensive solutions that leverages a strong network of partners committed to deeply caring about people. As **Partners in Wellness**, Medisca offers an unfailing devotion to improving lives, across a multitude of needs and across a multitude of people.

The main purpose of the **QMS and Documentation Specialist** is to ensure Medisca’s policies and procedures are incorporated into the Quality Management System and is effectively maintaining GMP compliance. They are expected to work in a team environment or independently to meet defined objectives based on established timelines.

**Responsabilities & duties**

Writing, reviewing, and updating Standard Operating Procedures (SOPs)
- Write SOPs according to regulatory and business requirements.
- Review and update existing SOPs as required in response to departmental or business needs.
- Responsible for the accuracy of SOPs within MasterControl.
- Responsible for maintaining a repository of business changes being proposed and determining implementation strategy through SOP change management.
- Lead SOP collaboration meetings to effectively document the changes while ensuring the language used is clear, concise, and understandable throughout the organization.
- Conduct training for new employees on writing and updating SOPs in MasterControl
- Responsible for the execution of all training activities as they relate to released SOPs and ongoing employee training requirements.

Support and Maintenance of the QMS
- Respond to all MasterControl support inquiries within the established KPIs.
- Launch change controls as required and following through from initiation to completion.
- Responsible for uploading quality related documentation in MasterControl based on assigned action items.
- Generate MasterControl reports and ensuring the accuracy of the data through continuous report monitoring.

**Qualifications**:

- Bachelor’s Degree in a Science related field required
- Five (5) to seven (7) years’ experience in Quality Assurance
- Knowledge of regulatory guidelines (USP, GMP, FDA, DEA, 21CFR, ISO, Health Canada Guidelines etc.).
- Knowledge of the Microsoft Office suite (Word, Outlook, Teams and Excel) required.
- Proven experience working with a QMS (MasterControl is an asset)
- Excellent communication skills; Fluent French and English (oral & written) required. This position requires communication with stakeholders from across Canada and the United States.
- Exceptional writing skills (clear & concise style, format and level of writing for audience)
- Meticulous, detail-oriented and able to work in a fast-paced environment
- Excellent time management and organizational skills.

**What’s in it for you**

We invest time and resources into making sure Medisca is as good as the people we hire.
- Work/Life Balance - 37.50 hour workweek with early Fridays all year long, PTO and vacation policy.
- Invest in your health - Choice of modular plans, health spending account and free Telemedicine.
- Your well-being is important - Wellness program offered.
- Your Future is Bright - Opportunities to learn and grow within Medisca.
- Save for your Future - Medisca contributes to a deferred profit sharing plan (DPSP) when you invest in RRSPs.
- Help us grow - Employee Referral Program.
- Central location - Free parking/accessible by public transportation; a commercial center is within walking distance for lunch or groceries.
- We like to have fun - Company events throughout the year.

We are an equal opportunity employer.

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