Job Description

Vacancy for Quality Specialist at Syneos Health 2023.

Job Title/Position:

Quality Specialist

Job vacancy for Pharmacy

India

End-to-End Corrective and Preventive Action (CAPA) management systems implementation and support
Work with business stakeholders on development of CAPA and effectiveness checks and follow-up with CAPA owners and Subject Matter Experts (SMEs)
Liaise with business stakeholders through CAPA Lifecycle Management
Track CAPAs through to completion, including updates to senior management and escalations as required
Assist in follow-up of open and overdue CAPAs with key business stakeholders to ensure accuracy and quality of data
Perform gap analysis of Quality systems and procedures and provide insights and feedback on continuous improvement areas
Develop and implement streamlined Standard Operating Procedures (SOPs)
Support client projects to establish or transform SOPs and associated controlled documents across the GxP spectrum, comprising text SOPs /policies /associated documents, smart forms and templates
Develop processes and flow charts in Business Process Mapping cloud environment.
Conduct quantitative and qualitative benchmarking and primary and secondary analyses of large and complex data
Research the GxP standards, regulatory authority websites

BA/BS degree in the science/health

One (1) to Three (3) years’ Pharmaceutical or Healthcare related industry experience.

Prior experience of working on clinical studies/trials.
Prior experience in authoring SOPs (within the GCP/GMP and any other GxP space).
Strong knowledge of all applicable Good Clinical Practice /other GXP regulations (as applicable) and guidelines. Knowledge of medical terminology preferred.
Well-developed communication skills and the ability to write and present concise, accurate documentation.
Ability to handle multiple tasks to meet deadlines in a dynamic environment and to adapt to work at different time zones.
Strong organizational, presentation, documentation and interpersonal skills with diverse cultures.
Ability to negotiate and provide constructive feedback.
Must be able to work as part of a team as well as independently.
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail.

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