Specialist – Quality Operations (GQS I)
Job ID: REQ-10049155
Location: India
Division: SANDOZ
Business Unit: Sandoz
Site: Mumbai (Office)
Functional Area: Quality
Employment Type: Full Time, Regular
Job Description:
As a Specialist in Quality Operations (GQS I), you will manage the end-to-end complaints handling process within the Quality Management System (QMS), ensuring timely resolution, regulatory compliance, and effective stakeholder coordination. This role is pivotal in supporting global quality operations and maintaining product quality and safety.
Major Accountabilities:
Complaints Management:
Receive and review initiated complaints in the QMS tool. Forward technical complaints to CMOs/Suppliers for investigation.
Coordinate with Country Organizations (CO) and CMOs to obtain complaint samples and additional investigation-related information.
Conduct periodic follow-ups with suppliers to ensure timely investigations.
Perform queries in QMS tools like GxQEM in accordance with defined procedures.
Review and complete supplier investigations in QMS for complaints delegated to GQSI. Act as QA approver for such complaints.
Monitor complaint and action timelines; track and apply extensions when required.
Manage associated child records, including Investigations and Communication actions.
Participate in meetings and discussions with sites and suppliers regarding complaint investigations.
Conduct quarterly trending and reporting for complaints/deviations; assess and manage signal evaluations in the QMS tool.
Minimum Requirements:
Education:
Degree in Pharmacy, Science, Engineering, or MBA from a reputed institute.
Languages:
Fluent in English (written and spoken).
Strong communication, presentation, and interpersonal skills.
Experience:
Minimum 7 years of experience in Quality Assurance, Regulatory Affairs, or pharmaceutical manufacturing (drug substances/products/medical devices).
Knowledge of GxP practices and basic IT skills.
Proven experience collaborating with global stakeholders.
What You’ll Receive:
Flexible working arrangements.
Learning and development opportunities for career progression.
Inclusion in a globally recognized company contributing to public health.
Why Sandoz?
Sandoz is a global leader in generic and biosimilar medicines, delivering over 900 million patient treatments across 100+ countries in 2024. With an ambition to go further, Sandoz offers you the chance to make a real impact in healthcare.
Join Our Network:
If this position doesn’t match your profile or goals but you’re interested in future opportunities, join the Sandoz Talent Pool.
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