Coordinator, Quality Assurance

Job purpose

The main responsibility for this position is to provide support for site-wide Quality Assurance Programs including GMP Documentation and Change Control to meet SUN Pharma, Canadian and FDA GMP requirements.
This position acts to oversee the processing of GMP Documents including revisions, posting, archival as well as maintenance and storage of GMP documents at the SPCI QA Documentation Center and Third-party Documentation Storage Facility.

• Organize and coordinate the archival, retention and retrieval of GMP Documentation generated at SPCI.
• Support Regulatory Inspections and Customer Audits through the timely retrieval of Documentation
• Support revision and posting (making effective) of Quality Control Documents (eg Test Methods, Specifications) and Master Production Documents as per assigned Change Control tasks in a timely manner
• Facilitate communication with stakeholders required for completion of Change Control tasks within assigned due date
• Support QC, QA and RA Departments by updating specifications, test methods required for regulatory submission as assigned and monitor and support the further implementation when approved by the Agency
• Support Production and QA Incoming Departments with maintenance of active and archived Engineering, Packaging specifications and Art Work electronic packets.
• Maintain and regularly review GMP Documentation inventory to assure timely closure of document requests, timely transfer of documents for archival at a third-party storage facility and provide support for timely GMP document destructions
• Act as a backup for Specialist, QA (Documentation) as per the business needs
• Generate, gather and analyze data to support specified Quality Systems:
  Documentation and Change Controls
• Generate reports associated with the specified Quality Systems:
  Documentation and Change Controls
• Perform assigned tasks for implementation of new Documentation related Software systems: eg EDMS, BRMS, as required.
• Perform assigned actions related to SUN global projects for documentation updates: eg rebranding of GMP Documentation, Art Work Rebranding.
• Participate in Internal Quality Audit and Internal Self-Inspection Program as assigned
• Complete required Department trainings within assigned due date
• Identify and report issues required improvements in the area of expertise related to the job duties and propose the enhancement to support the efficiency.
• Work with other departments to proactively build quality into the processes and systems
• Perform responsibilities in a GMP compliant and safety conscious manner
• Other duties as assigned

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

• Bachelor’s Degree or a College Diploma in a Science related discipline
• Previous experience in the pharmaceutical Industry in a Quality / Documentation Coordination Role is preferred
• High Proficiency in MS Word and Excel
• Sound knowledge of Health Canada and FDA regulations
• Good verbal and written communication skills
• Ability for Critical thinking and analyzing
• High attention to details and ability to stay focused when multitasking
• Ability to establish and prioritize daily work schedules in a fast-paced environment.
• Ability to work independently and under minimum supervision.
• Ability to identify discrepancies, deviation form procedures, issues related to completion of tasks and brought to the attention of management with logic, data and corrective measures proposed.
• Well-developed interpersonal and teamwork skills

• Ability to manage work under fast-changing priorities
• Numerous and varied responsibilities demanding attention and detail
• Working in general office and QA Documentation Centre
• Some physical lifting and carrying document boxes, as required

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This posting is for an existing vacancy.

The presently-anticipated base compensation pay range for this position is $56,500 to $71,000. Actual base compensation may vary based on a number of factors, including but not…