Serialization Process Specialist II
3 weeks ago
Job Summary
Serialized Product Traceability encompasses a set of Serialization and Track & Trace initiatives aimed at securing our supply chain to ensure safe, authentic products reach every patient, every time.
The Serialization Process Specialist II is accountable for process for all activities involving the serialization program of Septodont and Novocol Pharma.
The individual will be part a fast-paced team seeking to comply with a rapidly evolving landscape of global serialization regulations as well as leveraging new capabilities to improve the way Septodont makes and delivers products to patients. This role will interact with a wide range of business functions to understand processes, improve capabilities, and deploy new technologies quickly and effectively.
Responsibilities
The Serialization Process Specialist II is the Serialization System Owner for the corporation. This a list of job responsibilities:
Lead serialization compliance road map across the sites Develop business cases and strategic recommendations for meeting Serialized Product Traceability regulations. Engage with external parties and industry forums to determine best practices. Harmonize serialization processes across the sites. Maintain and update procedures as required. Drive cross-functional Track & Trace projects from beginning to end: from building relationships with key business stakeholders to collecting and analyzing data, Lead serialization equipment installation and qualification. Propose serialization solutions for overall engineering system. Review and integrate solutions into the serialization strategic plan. Troubleshoot serialization related issues. Formal investigation of support issues, communication with impacted stakeholders, vendors, resolution/closure of the issue, and updating appropriate knowledge management records Ensure on-time, on-budget delivery of SPT capabilities that meet business needs. Coordinates with remote teams in automation/software qualification and software validation activities and further provide assistance to serialization support team to manage serialization deadlines Point of contact for serialization vendors and building those relationships Lead serialization connectivity customers projects (eg. reporting of serialization data) Lead governmental serialization connections eg. Europe and Russia Coordinate artworks changes related to serialization Keep leadership in stakeholder functions apprised of project status, scope and challenges. Propose a strategic vision for future serialization projects (ERP, Block Chain…) Identify, evaluate, and implement Value Beyond Compliance applications of Serialization and Track & Trace capabilities to drive cost savings, improve operational efficiency, and ensure product quality.
Qualifications
Education
B. Eng required, P.Eng preferred.Experience
4 years of experience in serialization Good knowledge of serialization regulations Familiarity with Serialization and Track & Trace regulations: US DSCSA, EU FMD Knowledge of GS1 standards and guidelines (e.g. EPCIS) Ability to manage serialization projects. Demonstrate technical leadership for all Serialization IT systems. Ability to identify and mitigate risks associated with assigned projects by developing mitigation plans, following set escalation plans as necessary and proactively monitoring risks throughout the project. Review and critique external consultant and equipment supplier designs and review drawings. Excellent written and verbal communication skills. Effective interpersonal skills with the ability to work in a team environment. Proven analytical, trouble shooting and problem solving skills. Ability to work independently in a fast-paced environment. Ability to manage multiple projects concurrently Proven ability to work effectively in ambiguous situations and under tight deadlines Effective organizational, time management and detail-orientation skills. Ability to work with minimal supervision, taking initiative and prioritizing work. Flexibility to work all shifts within a 24-7 work environment.What we offer
Excellent compensation/benefits package. Bonus and reward programs Discounted gym memberships Programs supporting work life balance Employee recognition program Professional and personal development programs Social events and spirit daysWe are committed to diversity and inclusion, and thank all applicants in advance; however, we will be corresponding only with those selected for an interview.
In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier free recruitment and selection process.
Recruitment Fraud – please be aware of recruitment fraud. Novocol Pharmaceutical of Canada Inc. will never ask for banking information, money or any personal information up front. We will only respond to official applications submitted through our careers site. In addition, we will only use official corporate e-mail addresses (septodont.com or novocolpharma.com) to communicate with applicants. Should you be contacted without submitting an application, please delete the message and advise your e-mail provider.
Only for Internal Job Postings – Internal Job Posting Grade 10. The due date for internal applicants to apply for this role is April 16, 2024.
Contract type
Permanent
Candidate criteria
Minimum level of education required
3- Bachelor
Minimum level of experience required
2-5 years
Position location
-
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