Job Description

Job purpose

This position is responsible for the maintenance of the quality assurance and release systems to meet and ensure Canadian GMP and, regulatory requirements are achieved. This role is responsible for management of all the quality and compliance programs associated with Contract Manufacturing Organizations (CMOs) including their compliance assessments, audits and compliance metrics.

The incumbent holds responsibility over timely decisions on disposition of Finished Product batches manufactured by Contract Manufacturing Organizations (CMO\'s) for Canadian market 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.
• Review batch records, validation reports, shipping records and associated documents from CMO\'s required to comply with Canadian GMP and regulatory requirements
• Communicate in a timely manner with manufacturing sites on missing documentation and information necessary for site market release demand as required for CMOs.
• Update inventory management systems with appropriate lot status designation (reject, hold, quarantine and approved).
• Determine status disposition for returned goods, complete all necessary documentation and enter this information into the dedicated electronic system.
• Complete department metrics and reports; communicate with key personnel on the release timeframes.
• Support the management and relationship with CMOs to assure product quality and Canadian GMP and, regulatory requirements.
• Oversee the Annual Confirmatory testing, Retain Sample Management programs and the Annual Product Review (APQR) process for CMOs.
• Perform activities as an active user of electronic systems such as SAP, TrackWise etc,
• Review and evaluate risk on product quality for CMO initiated investigation impacting batches manufactured for Canadian market

• Manage the Unique Identifier (UID), Product Master File Management and Annual Executed Batch Review Program for CMO products.
• Proactively identify, evaluate and facilitate remediation of compliance risks.
• Maintain safe and healthy work environment by following standards and procedures; complying with legal, safety and IT regulations.
• Assist and/or train Taro and UPS team members on TARO products visual inspection, return and rejected materials as required

• Participate and provide quality input in review and revision of Quality Assurance, Compliance and other applicable procedures (SOPs).
• Consistently work with CMO\'s to proactively build quality into the processes and systems.
• Identify and implement key process improvements targeted to enhance systems, gain efficiencies, and elevate the site compliance level.
• Participate in the Product Recall activities with regards to inventory management and documentation as required.
• Complete Corrective and Preventive Actions (CAPA\'s) within established timeframe.
• Initiate, review, closeout and maintain of all internal and external change controls associated with CMO management in a timely manner.
• Provide support for Complaint investigations
• Participate in Internal and Customer Audits and Regulatory inspections.
• Complete all training assignments and maintain personal training records.
• Other duties as assigned.

• B.Sc. Degree in Chemistry, Biochemistry, Pharmaceutical Science or related field
• Minimum 5 years of experience in a Quality role within the pharmaceutical or related industry
• Sound knowledge and understanding of Health Canada and FDA regulations
• Proven problem-solving ability with evidence of good judgment and decision-making skills.
• 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

• Ability to work under stressful conditions and prioritize workload
• Non-routine and complex problems
• Dealing interdepartmentally/across sites to attempt to obtain facts in a rapidly changing atmosphere
• Numerous and varied responsibilities demanding attention and detail
• Stress tasks and environment during regulatory and customer\'s inspections

Sun Pharmaceutical Industries