Senior Associate, Quality Assurance (Licensing & Complaints)

Job purpose

Senior Associate, Quality Assurance (Licensing and Complaints) is responsible for ensuring products are manufactured, inspected, tested and packaged according to GMP and Company requirements. This position is responsible for the management and co-ordination of all the activities associated with Product Quality Complaints as well as establishment of the complaint process of quality complaints receipt including third part Call Center oversight and post marketing surveillance activities.

Duties and responsibilities

• Initiate the PQC record in TrackWise (as required)
• Send acknowledgement of complaint receipt to the complainant
• Support customer complaint and other investigations by logging complaints, gathering relevant information, issue final reports etc.
• Maintain complaint investigations databases
• Review and assess all complaints and other information about potentially defective product according to Sun Pharma Canada Inc. Complaint SOP using quality risk management principles
• Follow up with customer to obtain complaint samples or missing information for investigation purposes
• Notify the Site Leadership Team of PQC’s that may require a field alert or recall assessment
• Communicate Adverse Event cases with an associated valid PQC to PV Department
• Perform product quality complaint investigation as per Sun Pharma Canada Inc. Product Complaint SOP
• Assign cross-functional teams to support PQC process, if required
• Ensure adequacy, correctness and completeness of the overall Product Quality Complaint Investigation record
• Ensure mandatory impact assessment including impact to other batches and products
• Trend complaint investigations and support issuance of metrics
• Identify recurring non-conformances and product complaints and ensure appropriate actions are taken such as management notification
• Provide guidance and train the cross-functional employees on compliance aspects of the quality complaints
• Write and maintain SOPs
• Identify and implement key process improvements to areas to enhance systems, gain site efficiencies and elevate GMP requirements
• Work with other departments to proactively build quality into the processes and systems
• Participate in and/or lead Non-Conformance Investigations associated with complaints management
• Assist with activities related to the Recall process
• Assist with activities related to the site licensing process
• Establish and ensure periodic reconciliation process of quality and medical complaints; support LOE and ADE investigations
• Maintain the established process for complaint samples receipt, storage and destruction
• Create extension of the PQC (as needed).
• Complete investigation, document findings with appropriate root cause and Corrective and Preventive Actions (CAPA's) with SMEs
• Initiate, and follow through with actions required to close Change Controls
• Participate in Internal, Customer and Regulatory Audits
• Support the Product Inquiry Process
• 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

• Bachelor's Degree in Science, or related discipline
• Minimum 5 Years' experience in a Quality Assurance, Quality Control or Manufacturing experience role within the pharmaceutical Industry preferably in handling non-conformance or Complaints investigations
• Good working knowledge of pharmaceutical Quality Systems
• Experience in coordinating team activities
• Experience in dealing directly with Regulatory Agency officials (Health Canada and FDA)
• Sound knowledge and application of Health Canada and FDA regulations
• Knowledge of pharmaceutical standards, transfer guidelines, validation requirements
• Capable of leading by influence in matrix environment
• Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up, excellent communication and writing skills
• Experience in Quality electronic systems such as Trackwise, Learning Management System (LMS), Electronic Documentation Management System (EDMS),) and SAP is an asset

Working conditions

• Non-routine and complex problems
• Dealing interdepartmentally/across sites to attempt to obtain facts in a rapidly changing atmosphere
• Ability to work under stressful conditions and prioritize workload
• Numerous and varied responsibilities demanding attention and detail

Physical requirements

• Office based role

Regular hours are 8:00am to 4:30pm or 9:00am to 5:00pm, with extended hours as required to resolve urgent issues