Qms And Documentation Specialist

vor 1 Monat

Central Coast, Österreich Tideri Jobbörse Vollzeit

Description 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.
As Partners in Wellness , Medisca offers an unfailing devotion to improving lives across a multitude of needs.

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 effectively maintain GMP compliance.
They are expected to work in a team environment or independently to meet defined objectives based on established timelines.

Responsibilities 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.
Maintain a repository of proposed business changes and determine implementation strategy through SOP change management.
Coordinate meetings with different subject matter experts to understand the changes required to incorporate them into the impacted SOPs.
Lead SOP collaboration meetings to document changes clearly and concisely.
Conduct training for new employees on writing and updating SOPs in MasterControl.
Execute all training activities related to released SOPs and ongoing employee training requirements.
Support and Maintenance of the QMS
Respond to all MasterControl support inquiries within established KPIs.
Launch change controls as required and follow through from initiation to completion.
Upload quality-related documentation in MasterControl based on assigned action items.
Generate MasterControl reports and ensure the accuracy of the data through continuous monitoring.
Qualifications: Bachelor's Degree in a Science-related field required.
Five (5) to seven (7) years of 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 in French and English (oral & written) required.
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.
Proven abilities to apply good judgment, ethical practice, and decision-making skills.
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 thank all applicants for their interest; however, only candidates to be interviewed will be contacted.

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