工作内容: Senior Associate, Release
We are currently hiring a Senior Associate, Release for our client, a global pharmaceutical and life sciences company and one of the largest pharmaceutical companies in the world. The company is known for its global contribution in areas including pharmaceuticals, consumer healthcare products, agricultural chemicals, seeds, and biotechnology products.
This is a full-time 8-month contract with a possibility for extension and hybrid role. The Senior Associate will be responsible for the review and disposition bulk and finished products (including drug products, natural health products and medical devices), for Canadian manufactured/ packaged/ tested or imported products. Ensure that all activities have been performed in accordance with local, corporate, and regulatory requirements. Support the coordination and maintenance of Quality Systems.
- Review and disposition (approve/reject) bulk and finished products for market availability
- Liaise with supply centers to drive timely resolution of batch related issues
- Initiate or approve internal minor deviations. Approve deviations received from supply centers or contract manufacturing organizations
- Actively collaborate with internal/external stakeholders to understand the needs of the business. Plan, prioritize, communicate, and distribute team workload to drive business needs
- Communicate compliance expectations and provide compliance support to contract manufacturing organization (fabricators, laboratories, and warehouses) for product release requirements
- Initiate and/or approve change controls as well as ensure the timely completion of change control action plans associated with product launches, test methods and release related process changes
- Prepare or approve finished product release specifications
- Routinely monitor and review SOPs, data retention systems, GDPs, products and employee output for compliance and consistency
- Maintenance and retention of all QA documentation in accordance with quality system requirements
- Maintain and evaluate departmental KPIs to identify and action trends noted
- Support, participate and/or drive continuous process (efficiency and compliance) improvement or business/departmental initiatives
- Invoice approvals
- Deliver qualification training for new hires and coach junior staff
- College Diploma or University Degree in Chemistry, Biochemistry, or a related science
- At least 5 years+ experience in the pharmaceutical or a related industry (e.g., biologics, veterinary, natural health products). Experience working in a pharmaceutical manufacturing environment is an asset
- Customer focused, results driven and self-driven
- Plans and aligns as well as manages complexity
- Detail oriented with attention to accuracy, ability to independently organize and prioritize in a dynamic environment as well as manage multiple tasks
- Ability to work with minimum supervision. Can perform well independently or in a team-oriented environment
- Effective communicator, both written and verbal skills
- Sound understanding of documentation control principles, good manufacturing practices and quality system requirements
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Brunel Canada - Toronto