Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
Post : Quality Specialist
Job Description
• 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
Candidate Profile
• BA/BS degree in the science / health care field or equivalent combined education and experience.
• 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.
Additional Information
Experience : 1-3 years
Qualification : BA/BS degree in the science/health
Location : India
Industry Type : Pharma
End Date : 31st July, 2023
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