Description
Our client, a multinational in the pharmaceutical industry currently requires a: Control Document Manager
Location: South of Brussels
Duration: 6 months
Start date: ASAP
FUNCTION DESCRIPTION
The CDM (Control Document Manager) is responsible for:
* Implementing and maintaining the controlled document (POL/SOP/GUIs) management activities and systems by assuring the co-ordination of the development, review, approval, distribution, and withdrawal of controlled documents (CDs), including policies (POLs), Standard Operating Procedures (SOPs), and guidance documents (GUIs).
* Be accountable of specific documentation process improvement project(s) (eg creation of process map for a given Business with all the related CDs and trainings)
KEY RESPONSIBILITIES
* Evaluate need for CDs and determine the appropriate CD type
* Develop or update CDs in collaboration with the process owner to ensure compliance with other CDs and integrity of references
* Coordinate review of draft CDs by stakeholders
* Ensure CD readability and consistency with template
* Ensure communication of new and updated CDs to impacted functions
* Liaise with the training team which define a training strategy customized to the impacted functions
* Ensure that current CDs are periodically reviewed
* Withdraw CDs that are not useful anymore
* Supply CDs to users and auditors
* Present and defend the CD management processes during audits and inspections
* Maintain CD management systems (repository, training profiles, planning, etc.)
* Optimize and prioritize quality and productivity through robust and effective implementation of the Process Documents management systems.
* Liaise with other department and business units to ensure alignment on global strategy and to ensure stakeholder review for CDs impacting his/her own group.
* Look for continuous improvement and harmonization of the CD management and when appropriate collaborate with the Process Improvement department
* Ensure that the doc. process improvement project she/he will be responsible of will be properly managed and implemented
PREREQUISITES
* Minimum 3-5 years of relevant experiences in Control Documents management in a regulated environment
* Experience in Pharmaceutical companies is an asset