Associate, QA (Product Release) - Contract

Job purpose

This position is responsible for the maintenance of the quality assurance and release systems to meet Canadian GMP regulations, to ensure regulatory requirements are achieved and to provide quality oversight to the Sun Pharma Canada Inc. manufacturing site.

This position acts as an active influence towards elevating the quality practices and guidelines for products manufactured, packaged or tested at the Contract Manufacturer or out of Canada Sun Pharma Canada Inc. manufacturing facility.

The incumbent holds responsibility over timely decisions on market disposition decisions for finished products based on the comprehensive review process.

Duties and responsibilities

• Perform timely evaluation and make decisions on disposition of the finished product based on the review of all required documentation ensuring accuracy and compliance with the established Standard Operating Procedures and regulations. 
• Update inventory management systems with appropriate lot status designation (reject, hold, quarantine and approved).
• Complete department metrics and reports; communicate with key personnel on the release timeframes.
• Complete customer requests ensuring execution of the appropriate paperwork; send the samples to the customers in a timely manner.
• Perform activities as an active user of electronic systems such as SAP, TrackWise, LIMS and DocuSign etc.
• Ensure effective interactions with the external quality departments from CMO and Sun Pharma international sites.
• Consistently work with the manufacturing facilities and support to proactively build quality into the processes and systems.
• Lead temperature excursion investigations and ensure appropriate risk assessment completion prior to the batch disposition decision.
• Review and approve Investigations and Change Control records associated with the batch manufacturing.
• Ensure that the release process is completed as per the established check list and includes revision of the critical documents such as Certificate of Manufacturing, Certificate od Compliance etc.
• Ensure that Master Files are kept in a compliant and current manner.
• Send product samples for confirmatory testing as required.
• Participate in the Product Recall activities as required.
• Provide metrics to the manufacturing sites on the “Right First Time” approach.
• Complete Corrective and Preventive Actions (CAPA’s) within established timeframe.
• Participate in Internal and Customer Audits and Regulatory inspections.
• Complete all training assignments and maintain personal training records.
• Other duties as assigned.

Additional responsibility

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

• B.Sc. Degree in Chemistry, Biochemistry, Pharmaceutical Science or related field
• Minimum 3 years of experience in a Quality role within the pharmaceutical or related industry
• Sound knowledge and understanding of Health Canada
• Experience and/or knowledge of Pharmaceutical manufacturing and packaging is an asset
• Experience with SAP and Trackwise is an asset
• Skilled Word and Excel user
• Good written and verbal communication skills
• Ability to influence others while maintaining integrity and trust, by keeping a continuous focus on effective communications to ensure achievement of shared goals
• Strong organizational skills and ability to multi-task; attention to detail
• Strong troubleshooting and problem solving abilities
• Change leader and driver
• High energy level, self-starter
• People skills, ability to influence others

Working conditions

• Ability to work under stressful conditions and prioritize workload
• Numerous and varied responsibilities demanding attention and detail
• Stress tasks and environment during regulatory and customer’s inspections
• Regular presence on manufacturing/packaging shop floor in collaboration with Operation’s staff
• Rotating shifts

Physical requirements

Office based

Direct reports

N/A