Lead C&Q Document Controller

Posted 25 April 2022
DisciplineLife Science
Contact NameRonan Brady

Job description

Role: Lead C&Q Document Controller

Location: Dún Laoghaire

Contract Length: 12-months (potential extension).

Orion Group Life Sciences are currently recruiting a Lead C&Q Document Controller on behalf of our Multinational Biopharmaceutical client based in Dún Laoghaire.

Duties and Responsibilities:

  • Execute and develop document control project procedures that are in line with site SOPs for the C&Q team / Manager.
  • Support CQV activities across the project lifecycle (FAT, SAT / FT, IQ, OQ and Summary Reports)
  • Process incoming and outgoing documents including receipt, classification, registry, distribution, archiving, storage, and retrieval
  • Develop knowledge and understand project management principles, quality systems, quality plan and working procedures
  • Continuously identify opportunities of enhancements in the document control process
  • Management and co-ordination of CSR / CQSR Summary Reports for C&Q
  • Provide metrics to project management team on a weekly and monthly basis in relation to the status of documents (Generation, Execution, Review and Post-Approval phases) for the project
  • Participate in the development and implementation of project document control procedures under the supervision of the C&Q Project Manager
  • Attendance and report out at weekly project meetings as C&Q representative
  • Front-line enforcement of approved document control procedures across the project organisation and interface with other project participants and team members
  • Co-ordination and tracking of turnover packages from construction management team (VTOP, FTOP, Construction Handover Dossier CHD, System Completion Dossier SCD)
  • Conduct personnel Training on use of the various document control elements.
  • Management of redlined drawings for record as-builts for each phase of Qualification and Validation
  • Track progress of document creation and completion, and production of progress metrics and KPIs.
  • Communication with relevant parties to resolve potential issues in a timely manner.
  • Utilise, populate, and amend project documentation and collaboration platforms including EBuilder, CDOCs, Maximo, Fusion, KNEAT (electronic validation tracking systems)
  • Escalate delays with document delivery at tier meetings and ensure necessary actions are assigned.

Knowledge, Skills, and Experience Requirements:

  • Strong Interpersonal and organisational skills with the ability to work within a cross functional team
  • Work with all departments and with all levels of the organization, and with contract vendors engaged in design and construction.
  • Familiarity with documentation platforms such as EBuilder, CDOCs, Maximo, Fusion, Kneat, SharePoint, or similar.
  • Experience with complex projects and working in or around operating facilities
  • Knowledge of ASTM E2500 / Leveraging Verification process
  • 5 years plus experience working within a pharmaceutical GMP regulated industry
  • Experience of schedule driven capital projects would be an advantage
  • Familiarity with GMP and GDP concepts
  • Previous C&Q Document Control Experience on a Pharmaceutical Greenfield Project.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.