The Quality Assurance Specialist will support the implementations of the Quality Management Systems at LEO Pharma Inc. and maintain it to assure Compliance.
The Quality Assurance Specialist will receive, process, and close out cases for the Product Quality Complaints received for LEO product and ensure they are handled appropriately to sustain compliance with company standards SOPs and regulatory requirements. This individual will oversee and support the activities for the MyDoc LEO - Electronic Document Management System to stay current with individuals’ training status, update Master list of documents, keep track of individuals’ training requirements, and ensure that MyDoc LEO syllabuses for newly hired positions within the company comply with their training requirements and the current syllabuses are routinely updated upon new training requirements. This includes oversight for the overall document lifecycle. The Quality Assurance Specialist will assist the Quality Director in implementation of new Standard operating procedures, work instructions/processes, maintenance of implemented LEO Quality Management systems to sustain green level compliance, perform Self Inspections of company’s internal departments, and provide assistance during the audits from Health Authorities. This role will report directly to Director, Quality.
The position is also accountable for supporting business users on all functional matters relating to MyDoc LEO including maintenance of document metadata.
- Monitor and process incoming calls through Quality line, collect complaint/ inquiry information from customers, document details in IRMS (Global Complaint intake system) and ensure that the received complaints are processed according to the established procedure.
- Ensure accurate, organized and up-to-date records of complaints are maintained.
- Ensure timely complaint notifications are sent to third party vendors according to the existing procedures. Responsible for ensuring reconciliation of cases are performed and compliant with current processes.
- Prepare and disseminate weekly reports for Quality Complaints
- Responsible for communicating trends observed on reported complaints and/or specifics of lot number.
- Stay current in maintaining the Master list of documents. Ensure that new documents are added and the obsoleted documents are marked for the MyDoc LEO system (QMS requirement).
- Collaborate closely with People and Communications (HR) to maintain training syllabuses for new and current employees.
- Assist/ maintain a current list of all QMS activities that includes Deviation, CAPAs etc.
- Assist in generating the Audit Plan, schedules, CAPAs, and follow-up activities
- Complete all company-based and job-related training as assigned by LEO Pharma within the required timeline
- Additional duties as assigned by LEO Pharma Management.
MyQMS & MyDoc LEO Responsibilities:
- Provide end user support when required
- Maintain metadata on master documents
- Interact with department managers regarding training of documents
- Test Veeva updates before release
- Maintain access to external users
- Generate KPI reports
- Initiate periodic review workflows
- Address challenges and risks to the MyQMs and MyDoc LEO Business Lead
- Support the MyQMs & MyDoc LEO Business Lead when required
Required Skills:
- Requires 2-3 years of experience in Quality and/or Quality Assurance function in the pharmaceutical industry at minimum Quality Coordinator or similar level
- Bachelor’s Degree required
- Strong business acumen
- Strong computer skills including Microsoft Office Applications
- Ability to think strategically and tactically (detail-oriented)
- Strong collaborative and influencing skills, and ability to work well in a cross-functional, matrixed environment
- Analytical and problem-solving skills
- Excellent written and oral communication and interpersonal skills
- Meeting management/ facilitation skills / teamwork
- Flexible and able to adapt to company growth and evolving responsibilities
- Highly organized and ability to manage multiple priorities
- Ability to work independently and with various work groups
LEO Pharma Inc. is an Equal Opportunity/Affirmative Action Employer committed to an inclusive and diverse workforce that creates a better future for our global communities. Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Thank you for your interest in career opportunities at LEO Pharma Inc.
LEO Pharma Inc. seeks information for job applications from candidates in the U.S. through only the following channels:
- the LEO Pharma Inc. website and Halogen Talent Acquisition, powered by Jobvite
- via email to/from addresses using only the LEO Pharma domain of "@leo-pharma.com"
- screening and interaction by telephone and through the Microsoft Teams platform.
Please note:
- LEO Pharma does not use Google Hangouts, Zoom or any other platform for any recruitment-related activities.
- Disregard any solicitation or request for information related to job applications with LEO Pharma via any other means and/or using email addresses with any other domain.
- LEO Pharma will never ask candidates to make any type of personal financial investment related to gaining employment with the company.
If you have any questions about LEO Pharma Inc. and the application process, please email the company’s U.S. People and Communications team at HRUS@leo-pharma.com.