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Job #03600

About our client Our client is a pharmaceutical manufacturer based in Ontario. They have 11 state-of-the-art manufacturing facilities and plants, which allows them to simultaneously manufacture up to ten different active pharmaceutical ingredients. Due to a surge in growth in the past months, they are seeking an experienced Quality Assurance Manager to join their team. This is an excellent opportunity to join a career-focused environment! Position Location Quality Assurance Manager Ontario Salary Highly competitive package, commensurate with experience Responsibilities 1) Act as main contributor to the development of quality policies and procedures 2) Participate in the Corporate Audit Program and implementation of harmonized best practices across the company’s affiliate sites 3) Ensure effective, efficient and compliant QA systems and programs are in place, which include but are not limited to batch record review, product release/distribution, change control, quality event investigations (deviations, OOS), CAPA, official document control/archiving/destruction, annual product review 4) Handle final batch disposition and authorization of lot selection for distribution to customer 5) Manage workload and prioritize work in line with the overall department and company objectives and requirements adhering to defined targets and deadlines 6) Approve product shelf-life claims based on recommendations from the approved stability study procedures 7) Ensure stability programs are in place consistent with industry guidelines 8) Manage all compliance-related activities, like audit, third party investigations, contract manufacturers/laboratory and vendor qualification, annual product review and GMP training 9) Ensure product complaints/returned goods are adequately investigated, documented and appropriate corrective actions are taken 10) Communicate the resolution to customers 11) Ensure adherence to the responsibilities set out in Third Party Quality Agreements/Contracts 12) Make recommendation to senior management team for product recalls 13) Ensure compliant qualification and validation programs are in place 14) Provide necessary notification and maintenance of documentation as stipulated therein 15) Act as a consultant to the company affiliate sites on compliance and quality-related matters 16) Develop and ensure an effective and traceable communication network with the company affiliate sites is in place to co-ordinate and work on rollout or resolution of cGMP practices/issues 17) Host customer and government (TPP, FDA, EU) inspections in a manner that promotes good open dialogue and facilitates interaction with other departments 18) Work with related groups to document and implement appropriate corrective action plans to identify any areas of concerns, in a timely manner 19) Respond to customer-related queries, issues, complaints and documentation requirements (questionnaires, etc.) 20) Develop appropriate quality and compliance awareness/improvement programs and metrics and provide routine reports on performance 21) Foster an open and positive relationship/interaction with other departments from the management level through to the operational level 22) Ensure a co-operative and mutually respectful work environment is maintained resulting in rapid resolution of issues and achievement of company goals and objectives 23) Coach, develop and train QA staff in order to ensure sufficient backup/cross-training and depth to meet the requirements while creating an effective and motivated team 24) Conduct performance evaluations for reporting staff and review evaluations of other QA staff members 25) Identify promotional opportunities and remedial action plans for performance-related issues 26) Create and manage operational budget and expenses 27) Keep abreast of new regulations/guidelines, changes in GMP interpretation, emerging regulatory/industry trends 28) Ensure development, implementation and execution of implementation program 29) Use sound, technical judgment in making decisions and recommendations, and adhere to CGMPs and applicable SOPs when performing job responsibilities 30) Ensure effective, cGMP-compliant and efficient systems, procedures, programs and practices are in place 31) Ensure electronic information systems/databases are both effective and efficient and support the needs of the department and company 32) Ensure hard copies of official GMP documents are adequately maintained, controlled and documentation-retention policies are adhered to 33) Ensure a continual improvement program is in place both departmentally and cross-departments that considers compliance performance efficiencies 34) Recommend and implement enhancements on an on-going basis 35) Provide senior management with routine reporting on staffing, workplace management, performance, compliance, initiatives 36) Escalate issues for senior management awareness, intervention and support 37) Work independently or as part of a team, foster a positive work environment, provide support, guidance and functional direction to reports and other company employees 38) Conduct oneself in a respectful and professional manner both internally and externally, adhering to company policies and procedures Requirements 1) BS or degree in a related discipline 2) Minimum10 years of related experience in a pharmaceutical manufacturing company 3) Minimum 5 years of management or equivalent experience 4) Excellent knowledge of global GMP, pharmacopeial requirements and related regulatory/quality guidelines 5) Excellent communication (oral and written) and organizational skills 6) Highly developed problem-solving, interpersonal skills and decision-making skills 7) Good knowledge of MS Office suite 8) Demonstrated ability to negotiate effectively and a result-oriented team player