Serialization Process Specialist Ii
6 days ago
**General information**:
**Reference **:2024-1717
**Position description**:
**Job Title**:
Serialization Process Specialist II
**Company Details**:
Novocol Pharma is a growing contract development and manufacturing organization (CDMO), specialized in sterile injectable cartridges and combination product manufacturing. We strive for excellence and customer-centricity to deliver value to global pharmaceutical clients through contract services for drug development and commercial manufacturing. With over 40 years in operation, our team of 600 employees and modern facilities, located in Cambridge, Ontario provide a personalized and responsive experience for our customers. We are focused on serving our strategic partners and patients with quality, integrity, and value.
Our employees are our number one asset We offer developmental opportunities, excellent compensation and benefit programs, discounted gym memberships, work/life balance programs, employee recognition, social events and spirit days.
We are a proud member of the Septodont group of companies. Septodont is a pharmaceutical and medical device company with a global leadership position in dental pain management. The group counts over 2000+ employees worldwide and has remained a 100% family owned company for over 90 years. Our Cambridge facility serves as a significant manufacturing site within the Septodont group with high volume dental anesthetic production for a global customer base.
We have an opportunity for a Serialization Process Specialist II
**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 )
**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
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