Serialization Process Specialist II

Job title:

Serialization Course of Specialist II

Firm

Septodont

Job description

Place descriptionJob TitleSerialization Course of Specialist IIFirm ParticularsNovocol Pharma is a rising contract growth and manufacturing group (CDMO), specialised in sterile injectable cartridges and mixture product manufacturing. We try for excellence and customer-centricity to ship worth to world pharmaceutical purchasers via contract providers for drug growth and business manufacturing. With over 40 years in operation, our crew of 600 staff and fashionable services, situated in Cambridge, Ontario present a personalised and responsive expertise for our clients. We’re centered on serving our strategic companions and sufferers with high quality, integrity, and worth.Our staff are our primary asset! We provide developmental alternatives, wonderful compensation and profit packages, discounted gymnasium memberships, work/life stability packages, worker recognition, social occasions and spirit days.We’re a proud member of the Septodont group of firms. Septodont is a pharmaceutical and medical machine firm with a world management place in dental ache administration. The group counts over 2000+ staff worldwide and has remained a 100% household owned firm for over 90 years. Our Cambridge facility serves as a big manufacturing website inside the Septodont group with excessive quantity dental anesthetic manufacturing for a world buyer base.
Now we have a possibility for a Serialization Course of Specialist IIJob AbstractSerialized Product Traceability encompasses a set of Serialization and Observe & Hint initiatives aimed toward securing our provide chain to make sure secure, genuine merchandise attain each affected person, each time.The Serialization Course of Specialist II is accountable for course of for all actions involving the serialization program of Septodont and Novocol Pharma.The person will probably be half a fast-paced crew looking for to adjust to a quickly evolving panorama of worldwide serialization rules in addition to leveraging new capabilities to enhance the way in which Septodont makes and delivers merchandise to sufferers. This position will work together with a variety of enterprise capabilities to know processes, enhance capabilities, and deploy new applied sciences shortly and successfully.ObligationsThe Serialization Course of Specialist II is the Serialization System Proprietor for the company. This an inventory of job tasks:

• Lead serialization compliance street map throughout the websites
• Develop enterprise circumstances and strategic suggestions for assembly Serialized Product Traceability rules.
• Interact with exterior events and trade boards to find out greatest practices.
• Harmonize serialization processes throughout the websites. Keep and replace procedures as required.
• Drive cross-functional Observe & Hint initiatives from starting to finish: from constructing relationships with key enterprise stakeholders to amassing and analyzing knowledge,
• Lead serialization tools set up and qualification. Suggest serialization options for total engineering system. Overview and combine options into the serialization strategic plan.
• Troubleshoot serialization associated points. Formal investigation of help points, communication with impacted stakeholders, distributors, decision/closure of the problem, and updating applicable information administration information
• Guarantee on-time, on-budget supply of SPT capabilities that meet enterprise wants.
• Coordinates with distant groups in automation/software program qualification and software program validation actions and additional present help to serialization help crew to handle serialization deadlines
• Level of contact for serialization distributors and constructing these relationships
• Lead serialization connectivity clients initiatives (eg. reporting of serialization knowledge)
• Lead governmental serialization connections eg. Europe and Russia
• Coordinate artworks adjustments associated to serialization
• Maintain management in stakeholder capabilities apprised of mission standing, scope and challenges.
• Suggest a strategic imaginative and prescient for future serialization initiatives (ERP, Block Chain…)
• Establish, consider, and implement Worth Past Compliance purposes of Serialization and Observe & Hint capabilities to drive price financial savings, enhance operational effectivity, and guarantee product high quality.

{Qualifications}Schooling

• B. Eng required, P.Eng most popular.

Expertise

• 4 years of expertise in serialization
• Good information of serialization rules
• Familiarity with Serialization and Observe & Hint rules: US DSCSA, EU FMD
• Data of GS1 requirements and tips (e.g. EPCIS)
• Means to handle serialization initiatives. Display technical management for all Serialization IT programs.
• Means to establish and mitigate dangers related to assigned initiatives by creating mitigation plans, following set escalation plans as crucial and proactively monitoring dangers all through the mission.
• Overview and critique exterior guide and tools provider designs and evaluate drawings.
• Wonderful written and verbal communication expertise.
• Efficient interpersonal expertise with the flexibility to work in a crew atmosphere.
• Confirmed analytical, hassle capturing and downside fixing expertise.
• Means to work independently in a fast-paced atmosphere.
• Means to handle a number of initiatives concurrently
• Confirmed skill to work successfully in ambiguous conditions and below tight deadlines
• Efficient organizational, time administration and detail-orientation expertise.
• Means to work with minimal supervision, taking initiative and prioritizing work.
• Flexibility to work all shifts inside a 24-7 work atmosphere.

What we provide

• Wonderful compensation/advantages package deal.
• Bonus and reward packages
• Discounted gymnasium memberships
• Applications supporting work life stability
• Worker recognition program
• Skilled and private growth packages
• Social occasions and spirit days

We’re dedicated to variety and inclusion, and thank all candidates prematurely; nevertheless, we will probably be corresponding solely with these chosen for an interview.In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we’re dedicated to offering an inclusive and barrier free recruitment and choice course of.Recruitment Fraud – please pay attention to recruitment fraud. Novocol Pharmaceutical of Canada Inc. won’t ever ask for banking data, cash or any private data up entrance. We’ll solely reply to official purposes submitted via our careers website. As well as, we’ll solely use official company e-mail addresses (septodont.com or novocolpharma.com) to speak with candidates. Must you be contacted with out submitting an software, please delete the message and advise your e-mail supplier.Just for Inside Job Postings – Inside Job Posting Grade 10. The due date for inside candidates to use for this position is April 16, 2024.Contract sortEverlastingCandidate standardsMinimal stage of schooling required3- BachelorMinimal stage of expertise required2-5 years

Anticipated wage

Location

Cambridge, ON

Job date

Sat, 30 Mar 2024 06:20:41 GMT

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