This job has expired

Documentation Control Specialist

Employer
Sanofi Ireland
Location
Waterford
Salary
Negotiable
Closing date
20 Mar 2023

View more

Sector
Engineering
Job Type
Contract
Hours
Full-time

Job Details

Documentation Control Specialist- Waterford
About the Opportunity
Reporting to the Luna project manager as a key member of the QC Luna team, you will play an integral role supporting the QC Luna Digital Paperless project ensuring the creation, storage, issuance, and retrieval of all documentation in a manner which meets cGMP requirements.

This encompasses but is not limited to QC Luna project tasks, QC Day to day activities.

About Sanofi Business Unit
The multiple national award-winning Sanofi Waterford biopharmaceutical and medical device campus is located in Waterford on Ireland's southeast coast. Established in 2001 and now with more than 700 employees, the site has seen more than €600m invested in state-of-the-art infrastructure and technology.

Diversification continues to bring new products to Waterford and the expanded site portfolio continues to create new opportunities.

Key responsibilities

  • Define, manage, and maintain a documentation control system for QC projects & BAU cGMP documents.
  • Manage, index, and control the QC on-site and off-site documents
  • Create and maintain QC procedures.
  • Train QC site personnel on the Documentation Management Processes and QC Luna project implementation.
  • Define, manage, and maintain QC project key metrics ensuring site visibility, strong internal customer satisfaction and trending to support continuous improvement activities.
  • Supporting and providing appropriate information to support Product Performance Reviews (PPR).
  • Support and report right first-time documentation findings to support continuous improvement initiatives.
  • Participate in internal audits, support all external audits and any key quality Initiatives.
  • Ensure issuance and storage of QC and Projects documents.


About You
To excel in this role, you will need to have:
Essential requirements:

Qualification:

  • Leaving Certificate or equivalent and will preferably have secretarial and/or clerical qualification or accreditation

 

Experience:

  • Minimum of 3 years experience in similar role


Skills and Knowledge:

  • Very good knowledge of cGMP in a regulated
  • Excellent accuracy and attention to detail
  • Strong Planning/Organising skill
  • Customer Focus Driven with excellent interpersonal skills
  • Good Presentation skills
  • Working knowledge of computer systems
  • Personal development and goal management skills
  • Project Management skills and experience a distinct advantage


Personal Characteristics:

  • Excellent communicator
  • Flexible and adaptable- comfortable and open to change
  • Works well across all levels of the organization
  • Works on own initiative in a self-directed manner with minimal supervision
  • Highly motivated and focuses on achieving results
  • Excellent attention to detail


Play To Win Behaviours:

  • Stretch: Ability to go out from comfort zone to serve better
  • Take action: Prioritize outcomes over activities
  • Act for Patients & Customers: Actively engage with them to understand their needs now and in the future
  • Think One Sanofi: Believe that we'll go further together and have more fun doing it.

 

Apply today or contact myself at [email protected] for further information.

Company

Sanofi Ireland has 800 people working every day to serve those with health needs in Ireland and around the world. Wherever the team members are based, they all share the values of Teamwork, Integrity, Courage and Respect and their  common purpose:  Empowering Life.

Their manufacturing campus in Waterford has more than 740 skilled people working across multiple products and platforms, supplying therapies to people in over 70 countries. Sanofi continue to expand, providing opportunities for people to join the team, and help us support their No1 stakeholders; the people we provide our medicines for. 

Their dedicated team based out of Dublin bring a broad range of treatments to people across Ireland. Amongst our treatments we have consumer healthcare, vaccines, and medicines for cardiovascular disease, diabetes, multiple sclerosis, thrombosis, rare diseases and atopic dermatitis.

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