Product Labeling and Documentation Support technician

Product Labeling and Documentation Support technician

  Not Disclosed

  Hazelwood, MO

  6.0 Months

  Not Disclosed

  Not Disclosed

  Pharmaceutical

Job Description

Job Description
Primary Purpose and Overall Objective of the Job:



The Product Labeling and Documentation Support technician provides support to routine PLD within an operational hub. They ensure the application of processes necessary for the realization and delivery of product labeling deliverables (Instructions for Use, CD/DVD, labels, etc.) through conception and delivery.

Main Accountabilities:

• Perform quality checks and verification of labeling deliverables. Understand and ensure compliance to client quality standards and regulations as they apply to labeling.

• Participate to the resolution of complaints, CAPA, and investigations. (Level 12) Represent PLD in the resolution of complaints and CAPAs (level 11).

• Create PDFs and physical supports (DVD/CD/USB/Paper) in accordance with the project needs. Publish labeling deliverables in Livelink, and the technical library.

• Act as PLD Document Control Authority (DCA) for PLD workflows and ensure the appropriate metadata. Enter and verify labeling data into appropriate systems (SAP, PL-DMT, MDM).

• Update documents and labels in legacy systems as needed.

• Request quotations and follow-up on orders for PLD.

• Prepare and provide files to translation providers and integrate translated files into the appropriate system on their delivery.

• [For native speakers/qualified English speakers] Perform peer review and edit of documents written in English by non-native writers. Translate to English as needed.

• Process change requests related to labeling and provide support to PLD representatives and project teams as needed for labeling delivery. Process the ECO in SAP.


Typical Studies-Experience, Skills and Qualifications:

Studies-Experience:

- Associates degree (level 12) in a related field (quality system, labeling, communication, information technology).

- Associates degree with an experience of at least 3 years in labeling or quality system management (level 11).

Skills and Qualifications:

- Business English writing skills (level 12) and oral (level 11).

- Knowledge of client products and processes.

- Leadership and ability to communicate the needs/constraints of the department to contacts (level 11).

- Ability to work in a multi-cultural environment (level 11).


Scope and Resources Accountability, Typical Performance Indicators:

- Scope and Resources Accountability: Complexity of documents managed and level of involvement in international projects involving multiple operational hubs.

- Financial Indicators (revenue, budget, etc.): N/A

- Key Performance Indicators (KPIs): Number of anomalies directly linked to our documents and process (publication missing, wrong metadata, PL-DMT or Data update, etc.).

- Key Contacts (internal/external) and Interfaces: Internal: PLD hubs teams, Regulatory Affairs, Quality, Program/Project Managers, GCS, Legal, Production, IS, Supply Chain, Marketing. External: Translation Providers, subsidiaries.
VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status