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Premium Employer

Sandoz

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4.0

based on 385 Reviews

327 Sandoz Jobs

Specialist - Quality Operations (GQS I)

Sandoz

4.0

based on 385 Reviews

6-8 years

Warangal, Hyderabad / Secunderabad, Nizamabad

1 vacancy

Specialist - Quality Operations (GQS I)

Sandoz

posted 9hr ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy SAP CO Medical Devices Agile Coaching Process Improvement GMP

+ 1 more

Job Description

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our new Sandoz!

Job Purpose:

Provide quality services in compliance with cGMP requirements and Sandoz Quality Management System as defined and agreed between GQSI and business partners. Manage Quality aspects & projects within area of responsibility.

Job Description

Your Key Responsibilities:

Your responsibilities include, but not limited to:

Adherence to the current GxP and compliance requirements of Sandoz, perform and deliver Quality Operations in support of product quality compliance and regulatory workflows. Ensure compliance to the Sandoz quality standards, relevant regulatory requirements, filed product quality standards and service level agreements.

Support implementing service quality and process improvement projects, CAPA management within GQSI. Comply with internal functional requirements such as KPI reporting, ticket management tools and any other internal procedures and processes. Regularly communicate with customers and partners to collect feedback on support services, report deliverables.

Focus on timely completion of all relevant and assigned trainings. Learn & develop understanding to generate insights through data and digital. Ensure responsibility and ownership of the assigned tasks. Comply with accuracy and timeliness of deliverables. Hold accounts in workflow applications (such as SAP, GxQEM, CONDOR, ESOPs, TrackWise etc.) to ensure appropriate execution of service deliverables.

Generate and analyse predefined and ad-hoc reports in various applications (like Trackwise, GxQEM, etc.) and perform follow-up actions, if required. Escalate service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures. Assist the department on any other ad-hoc activities/ requests to meet the business requirements.

Provide active support during internal and external audits by collecting and presenting the requested process/ data and reports. Learn & develop understanding to generate insights through data and digital. Support the Master Data Management to the required sites as required. Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as needed.

What you ll bring to the role:

Minimum Requirements:

Education: Pharmacy/ Science/ MBA / Engineering/ equivalent from a reputed institute.

Languages:

Fluent in English (written and spoken)
Good communication, presentation, and interpersonal skills

Experience:

Minimum 5 years of experience in Quality Assurance/Quality Control, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices
GxP knowledge, Basic IT knowledge
Experience of working closely with the global stakeholders

You ll receive:

Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

Skills Desired

Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

Employment Type: Full Time, Permanent

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