Job Background
The RS (Resourcing Solutions) department of Chiltern International acts in a similar way to that of a staffing solutions provider. The department is currently seeking a Process Document Manager to work for our client, a global Biological company at their offices in Wavre, Belgium. The role is a 6 month contract which maybe extended candidates can either be employed through Chiltern International or work on a freelance basis.
Job Primary Functions
The executor of a Process Document (PD) Management mission is responsible for:
Implementing and maintaining the process document (POL/SOP/GUIs) management activities and systems by assuring the co-ordination of the development, review, approval, distribution, and withdrawal of process documents (PDs), including policies (POLs), Standard Operating Procedures (SOPs), and guidance documents (GUIs).
The Key Responsibilities of the executor of a Process Document Management mission will be:
Evaluate need for PDs and determine the appropriate PD type
Develop or update PDs in collaboration with the process owner to ensure compliance with other PDs and integrity of references
Coordinate review of draft PDs by stakeholders
Ensure PD readability and consistency with template
Ensure communication of new and updated PDs to impacted functions
Liaise with the training team for defining a training strategy customized to the impacted functions
Ensure that current PDs are periodically reviewed
Withdraw PDs that are not useful anymore
Supply PDs to users and auditors
Present and defend the PD management processes during audits and inspections
Maintain PD 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 PDs impacting his/her own group.
Look for continuous improvement and harmonization of the PD management and when appropriate collaborate with the Operational Excellence departments.
Job Qualifications
Education
University degree or equivalent combination of education and experience with a major concentration in the biological/pharmacy/health sciences area/quality assurance.
Skills
Oral and written communication skills, including the ability to communicate via formal and informal discussions with all levels of staff; organizational sensitivity in communications with senior and executive staff
Ability to operate cross-functionally and cross-departmentally in a multicultural environment, demonstrating a good team spirit
Analytical skills, including the ability to gather, summarize and interpret complex information from multiple internal and external sources
Demonstrated strong planning and organizational skills, being proactive.
Excellent knowledge of written & spoken English
IT Knowledge: Microsoft Office and PD management tools (e.g: knowledge of VISIO is an asset)
Experience
Have around 3 years experience in the pharmaceutical industry and able to adapt to the international regulatory requirements applying to clinical development, pharmacovigilance or regulatory affairs
To apply for this position or for more information about the role please contact Nicky Cooke on + 44 (0) 1753 216 729 or nicky.cooke
chiltern.com
