Sandoz logo
Sandoz

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported! Join us, help us make healthcare fairer and faster. We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Specialist, QA Batch Release

Location

Canada

Posted

8 days ago

Salary

0

Seniority

Mid Level

Job Description

Specialist, QA Batch Release

Sandoz

Role Description Ensure continuity of service to external customers (patients) by releasing batches to the Canadian market while ensuring the quality of finished products manufactured by our global suppliers (affiliated sites, ESO, and other suppliers, including subcontractors). Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! Your Key Responsibilities - Batch Review / Approval / Release of Bulk and Finished Products. - Ensure optimal planning of batch record review and execution of activities related to batch release, while considering potential impacts on customers and the supply chain (e.g., shortages, penalties, life-saving products). - Support prioritization and maintain ongoing communication with all contributing departments to ensure product availability on the Canadian market. - Review master manufacturing documents and packaging records from all suppliers. - Initiate deviations when non-conformities are identified. - Verify retention samples related to complaints (biweekly travel required to an external logistics warehouse). Qualifications - Bachelor’s degree in science or an equivalent field. - Minimum of 3 to 5 years of experience in quality assurance and with Canadian regulations. - Minimum of 2 to 3 years of experience with batch releases. - Minimum of 2 years of experience working GMP. - Proficient in MS Office Suite with knowledge of SAP. - Fluency in oral and written French is mandatory. - Oral and written fluency in English is required for regular communication with customers, partners, and/or colleagues. - Position based in Ontario, ideally in the GTA. - 100% remote position. - Owning a car and a valid driver’s license. - High level of autonomy and adaptation. - Excellent organizational skills and ability to manage priorities efficiently. - Strong attention to detail and rigor. - Analytical mindset and sound judgment. - Excellent communication and collaboration skills. Requirements - Knowledge of Power Query and Power Automate – an asset. Benefits - A minimum of three weeks’ vacation. - Paid time off in addition to your annual vacation and statutory holidays. - Time back between Christmas and New Year’s Day with full pay. - Group pension plan with substantial employer contributions. - Generous and flexible group insurance coverage through our private plan. - Employee and family assistance. - Telemedicine services. - Parental leave – supplemental top-up payments up to 100% of base salary, regardless of gender or sexual orientation. - Career enhancement and development, including learning, training and professional recognition opportunities. Company Description Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported! Join us, help us make healthcare fairer and faster. We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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