Job Description

Updated: Yesterday
Location: Pune, MH, India
Job ID: 25102778
Description Associate QA ( 1 yr contract - Client base - Mumbai)
Syneos HealthA is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youa??ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture a?? where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives a?? wea??re able to create a place where everyone feels like they belong.

Job Responsibilities
Looking for

• Minimum 2 years of experience in Medical Affairs or a related field, with a solid understanding of the current pharmaceutical environment.
• Proficiency in Microsoft Office programs including Word, Excel, PowerPoint, and Outlook.
• Strong ability to multitask and prioritize competing demands effectively.
• Relevant experience in project management is highly desirable.
• Demonstrated ability to work cross-functionally, with an agile mindset, and as a strong team player.

JOB RESPONSIBILITIES

• Support the implementation of PSEA awareness activities and encourage completion of mandatory training for relevant groups.
• Participate in the development, implementation, and enhancement of processes, controls, and tools in collaboration with cross-functional teams.
• Monitor actionable metrics and KPIs, initiate remediation actions as needed, and escalate concerns to the Medical Operations Manager or local PSEA Committee for recommendation or arbitration.
• Track compliance metrics for Patient Programs and related initiatives by preparing reports and trend analyses at defined intervals.
• Coordinate regular review meetings with internal stakeholders for Patient Programs and other related activities.
• Support end-to-end governance for defined Medical controls, processes, and activities within the responsible country, including monitoring metrics.
• Enforce medical compliance in alignment with global policies, ensuring all medical activities adhere to the highest ethical standards.
• Act as backup for operational implementation of Events & Scientific External Experts (SEE) engagement approval and monitoring process.
• Act as backup for coordination of the 4M approval process.
• Contribute to or facilitate projects aimed at simplifying and optimizing medical processes, performance, or governance.
• Support activities related to continuous process improvement for medical operations and governance.
• Assist in tracking planned and scheduled audits in the Enterprise Quality Management System (EQMS).
• Update audit schedules and calendars as requested by management.
• Gather documentation required for audits and inspections (e.g., training records, organizational charts).
• Assist auditors in obtaining follow-up information during customer audits and regulatory inspections.
• Enter audit-related data into the Enterprise Quality Management System and maintain QA documentation archives.

We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, youa??ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the . The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary Supports the auditing team in gathering documentation for audits and inspections and tracking the schedule of audits and inspections in the enterprise quality management system.
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