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QD Managers/Writers :
Interact with process improvement project teams to review and provide feedback on process maps and related documentation, clarify ‘to be’ processes and obtain additional information update/finalize process maps in collaboration with process improvement project team.
Develop QDs (SOPs, Working Instructions and Supporting Documents – templates, checklists, etc.), using corporate templates and writing rules.
Manage QD review & approval process, follow up with business representatives and process owners, organize & chair review meetings.
Revise/update QDs according to decisions made by team.
Peer QC of content of QDs.
QC compliance of QDs against writing rules/templates and other regulations, links/references, macros and consistency across QD package.
Coaching & QC for technical implementation teams on Business & technical document (BTD) development.
Quality compliance QC for BTDs
Provide input into information letter
Status reporting & associated administration
Attend regular QDF team meetings
Tracking and reviewing change control documentation. Assist with the editing of quality documents (SOPs, guidelines, validation master plans, etc.) to ensure compliance with regulator requirements. Must be able to work quickly with a high degree of accuracy. Must possess sound interpersonal and information gathering skills, being able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others. Prepares and/or maintains documentation pertaining to programming, systems operation, and user documentation. Translates business specifications into user documentation. Plans, writes, and maintains systems and user support documentation efforts; including online help screens. Knowledgeable of commonly used concepts, practices, and procedures within a particular field. Relies on instructions and pre-established guidelines to perform the functions of the job.
Responsible for designing, developing, and updating required technical documentation. Responsible for technical writing/editing for all types of documentation produced within a modern software development environment. Utilizes knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality.Documents programming standards and procedures.
Skills:Certified in Business Process Management (BPM) methodology - Use of meeting management tools and systems - Use of process design tools
Bachelor degree in a scientific/health-related field and 5 years of experience in the pharmaceutical industry, with 3 years of experience in clinical and/or quality operations-related roles (e.g., direct study management, monitoring, project management). Experience working within a global team/environment to produce operational reference standards to meet regulatory requirements across regions.
- Quality focused with a high degree of personal accountability and commitment.
- Ability to analyze business processes.
- Excellent skills to communicate and collaborate with project teams, departmental associates, internal and external partners.
- Demonstrated ability to anticipate problems/ changes impacts, consequences, and delays; work proactively and take the initiative for corrective measures.
- Excellent team leadership skills - Strong facilitation skills: ability to lead effective cross-location and cross-functional meetings, through discussions on complex and potentially controversial topics. Ability to recognize issues that may require escalation to management level.
- Ability to multi-task, handling a wide range of small, medium and long-term assignments in parallel and dealing with urgent issues as they arise. Ability to prioritize assignments in accordance with assigned project deadlines.
- Excellent written and verbal skills.
- Excellent presentation, interpersonal and communication skills (written and verbal)
- Competent in English (both written and verbal) to interact effectively in an international environment.
Languages:English Read Write Speak
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