Associate, Quality Assurance (Annual Product Review Program)

Job purpose

The main responsibility of this position is to prepare technical reports to support Annual Product Quality Reviews in compliance with Sun SOP’s, Health Canada and FDA requirements.  This position acts as an active influence towards elevating the quality practices and guidelines for manufactured and packaged product at the Sun facility.

Duties and responsibilities

• Review compiled data for relevance to product history.

Prepare technical reports that assess product attributes and marketing history for Annual Product Review Reports. Review compiled data for product history in order to determine any trends and appropriate corrective/preventive actions.

This may include any of the following: 

• •  Raw materials 
  •  Packaging components 
  •  Product specifications
  •  Method validation
  •  Master Batch records
  •  Master Documentation (Packaging Work Orders)
  •  Quality history (Investigations, Change Controls, Rejects, FAR, Recall, CAPA, etc.)   
  •  Product validation

• •  Equipment Status

• Prepare Master documentation Summary Report.
• Review and assess Quality history (Investigations, Change Controls, Rejects, FAR, Recall, CAPA, etc.) and Product/Equipment Validated status.
• Prepare Executive summaries and provide conclusions from the Report.
• Make APR recommendations as they relate to each product for process improvements.
• Initiate Change Controls and/or CAPAs as required as a result of the product quality review.
• Evaluate previous recommendations and CAPAs in assessing status of currently marketed product.

• Retrieve data from various sources (LIMS, Trackwise, SAP, MES, Change Controls, investigations, rejects, complaints etc.) both electronic and hard copy.
• Review data and reports for product quality review.
• Prepare reports and spreadsheets in standardized formats.
• Provide back up support to QA Stability team- preparation and review of stability summary reports
• Other duties as assigned

Additional responsibility (Only applicable to customer facing roles)

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

Qualifications

• BSc in Chemistry
• Minimum 2 years of experience with the Pharmaceutical industry combined with knowledge of compliance requirements for the pharmaceutical industry.
• Strong technical writing ability in a scientific discipline.
• Knowledge of manufacturing processes for creams, ointments, gels etc is considered an asset.
• Ability to interpret and analyze data utilizing statistical data software preferred
• Knowledge/ experience with software applications LIMS, Minitab and Trackwise preferred.
• Ability to communicate and work effectively in a team-based environment combined with good written and oral communication skills.
• Strong organizational and multi-tasking ability in order to accommodate change in priorities. 
• Proficiency with applicable computer software (Word, Excel) Proficiency with applicable computer software (Word, Excel)
• Strong organizational and multi-tasking ability in order to accommodate changes in priorities.
• Ability to manage time effectively and work efficiently to meet deadlines.
• Somewhat routine issues, infrequent unusual situations (eg computer application problems)

Working conditions

Generally, fairly pleasant surroundings typical of the average office.  Fairly level temperatures.  Mostly consists of sitting at computer terminal for the bulk of the day (6 hours), some light lifting.

Physical requirements

Office based role