Integration Procedural Documentation Manager - FSP
Primary Location: South Africa, Remote ID de la oferta R0000040342 Categoría Quality Management
sobre este trabajo
JOB RESPONSIBILITIES
Developing SOP mapping between sponsor SOPs and the aquiree’s sponsor/contract research organization (CRO)/vendor procedural documentation
Conduct comparison assessments between the procedural documentation to identify major gaps and work with the business process owner and SOP authors to validate
Facilitate the risk assessment of gaps with the business and document any interim procedures to mitigate the risk
Develop the official transition communication (using templates)
Develop the retirement strategy
ORGANIZATIONAL RELATIONSHIPS
Head of SOPs
SOP Acquisition Lead
Business Process Owners (BPOs) for clinical, medical, safety, regulatory and quality management system process areas
SOP Authors for clinical, medical, safety, regulatory and quality management system process areas
Quality organization colleagues
Sourcing Risk & Compliance
Project Management Office (PMO) Colleagues (PMOs are established per business deal)
QUALIFICATIONS / SKILLS
BS/BA Degree plus 5+ years Pharma experience.
Demonstrated experience in project management and implementation techniques.
GxP experience and a strong working knowledge and understanding of drug development processes.
Required: Proficient in Microsoft applications (i.e., Word, Excel, TEAMS)
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