Associate QA

Syneos Health

2 - 7 years

3 - 6 Lacs

mumbai

Posted:22 hours ago| Platform:

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Skills Required

career development remediation project management process improvement pharma agile http operations recruitment auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

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 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 we 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.

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