Περιγραφή εργασίας

Job Purpose: 
The purpose of this position is to be responsible for managing and supporting Remedica’s serialization and Track & Trace systems, ensuring accurate serialization data, system functionality, and compliance with applicable regulatory requirements and company procedures. The role supports production and packing operations, trading-partner connectivity, troubleshooting, and data reconciliation while ensuring compliance with GMP, GS1, EU FMD, and data integrity requirements.  support Maintenance Engineering activities, ensuring the proper functioning, compliance, and improvement of facilities, utilities, and engineering systems in accordance with established procedures and regulatory requirements.

Duties & Responsibilities: 

• Communicating with European Medicine Verification Organization (EMVO) and other non-EU national systems to establish and maintain the serialization accounts of Remedica LTD; ensuring that the accounts are always active
• Administering and configuring the company’s Level 4 (L4) enterprise serialization platform (TraceLink), or equivalent), including network-level master data and number-range management, EPCIS event data exchange.
• Configuring the Track & Trace system to implement serialization procedures as per the Production Batch Manufacturing Reports, including product master data and GTIN set-up, and serial-number range provisioning.
• Managing aggregation and disaggregation processes
• Reviewing guidelines and ensuring the technical capability of current system to implement the serialization requirements, in line with GS1 standards and EU Falsified Medicines Directive (FMD) requirements.
• Communicating with Marketing Authorization Holders (MAHs) to establish and maintain a safety communication channel to exchange information regarding the serialization project (portal communication or Business-to-Business connection)
• Leading trading-partner onboarding on the L4 platform – establishing, configuring, testing, and validating connections and EPCIS data exchange with MAHs, CMOs/CDMOs, customers, in accordance with documented onboarding procedures (partner master-data set-up, connection qualification, and go-live sign-off).
• Communicating with customers to ensure the receipt of the serial numbers (SM), applying the SM to Remedica’s products and forwarding the serialised information to the customer
• Performing serial-number reconciliation at batch close-out (commissioned, used, rejected, destroyed) and reporting status to MAHs and competent authorities in accordance with the approved SOPs.
• Providing training to new employees for the Track & Trace system as and when required
• Supporting the Qualification/Calibration team with the conduction of test regarding the Serialization process
• Assisting with the set-up of serialization machines in packing departments as and when needed, including configuration and support of Level 2–3 equipment (vision systems, printers, and line/site serialization servers) in coordination with packing and engineering.
• Monitoring the serialization databases to ensure that serialized data is either sent to the Marketing Authorisation Holder or is uploaded to the relevant system according to the relevant instructions as per the approved SOPs.
• Ensuring that all functionalities of the department comply with the established regulations and guidelines such as Standard Operating Procedures (SOPs) and the current Good Manufacturing Practices (cGMP). This includes initiating deviations, supporting CAPAs, following change control, and maintaining data integrity (ALCOA+, audit-trail and 21 CFR Part 11 / EU GMP Annex 11 controls).
• Carrying out any other duties as assigned by the Serialization and Aggregation Manager and/or COO.

Qualifications and Skills:

• Bachelor’s degree in Electrical or Mechanical Engineering, IT or any other related field. Programming knowledge is required.
• Previous experience in serialization, manufacturing systems, or a related technical role within a pharmaceutical or regulated environment is preferred
• Ability to work independently and collaboratively, follow verbal and written instructions, and interact effectively with internal teams and external stakeholders.
• Good knowledge of Greek and English (written and spoken).
• Advanced use of Track & Trace systems, serialization databases, and Microsoft Office tools.
• Hands-on experience with a Level 4 (L4) serialization platform (e.g. TraceLink, SAP ATTP, Systech, or equivalent) is required.
• Sound understanding of regulated electronic-data controls (data integrity / ALCOA+, audit trails, 21 CFR Part 11 / EU GMP Annex 11)

What’s in it for you?

• 13th and 14th salary.
• Provident Fund.
• Group Medical Plan.
• Discount scheme.

Πώς να υποβάλετε αίτηση

If you are interested, you can apply via our website: Serialization Engineer Job Details | Remedica Limited

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Remedica Ltd