
Pharmaceutical Compliance Specialist
5 days ago
This role involves working with the North America Sites Quality team to prepare, review, trend, and monitor quality-related activities and documents.
The individual will perform multiple assignments simultaneously while working independently with site stakeholders as appropriate.
Key Responsibilities:
- Collation of data and drafting the Annual Product Reviews
- Work with North America manufacturing sites to help complete the Product Quality Complaint records in TrackWise System
- Collate and prepare PQC trend reports for products and trending on defined frequency as per SOP
- Perform gap assessments of site SOPs vis-a-vis the global documents and derive actions required for revision of site SOPs
- Support the North America sites for routine revision of SOPs
- Support the North America site in assessment and mitigation of global actions in a timely manner
- Perform assessment and review of annual batches on stability for batches manufactured at different sites and imported by Sun Canada for distribution in Canada market
Minimum Qualifications:
- Master's degree preferred
- Role supporting seminars and courses are an asset
Desirable Skills:
- Thorough understanding of GMPs specifically those relating to good documentation practices, quality management system, complaint handling, etc.
- Ability to work effectively in an international multicultural matrix organization
- Expertise in software applications such as MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, TrackWise, Document Management System, LMS, etc.
- Strong communication, interpersonal, and organizational skills
- Fluency in English language will be required
Travel Estimate: Up to 10%
Education and Job Qualification: Minimum of five (5) years of experience within the pharmaceutical industry
OthersThe preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.
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