Specialist - Quality Operations (GQS I)
Job ID: REQ-10034940
Date: 02/01/2025
Location: India
Job Description
Your Key Responsibilities:
Your responsibilities include, but are not limited to:
Adhere to the current GxP and compliance requirements of Sandoz, performing and delivering Quality Operations in support of product quality compliance and regulatory workflows. Ensure compliance with Sandoz quality standards, relevant regulatory requirements, filed product quality standards, and service level agreements.
Support implementation of service quality and process improvement projects, CAPA management within GQSI. Comply with internal functional requirements such as KPI reporting, ticket management tools, and other internal procedures and processes. Regularly communicate with customers and partners to collect feedback on support services and report deliverables.
Complete all relevant and assigned training in a timely manner. Develop an understanding to generate insights through data and digital tools. Take responsibility and ownership of assigned tasks, ensuring accuracy and timeliness of deliverables. Execute service deliverables using workflow applications (such as SAP, GxQEM, CONDOR, ESOPs, TrackWise, etc.).
Generate and analyze 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 with any other ad-hoc activities or requests to meet business requirements.
Provide active support during internal and external audits by collecting and presenting requested process data and reports. Support Master Data Management for required sites as needed. Create and review GxP documents, including SOPs, working procedures, trend reports, qualification reports, and technical investigations.
What You’ll Bring to the Role:
Minimum Requirements:
Education: Pharmacy/Science/MBA/Engineering or 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 manufacturing of pharmaceutical drug substances/products/medical devices.
GxP knowledge and basic IT knowledge.
Experience working closely with global stakeholders.
You’ll Receive:
Flexible working arrangements to support work-life balance.
Learning and development opportunities, including mentorship programs and access to global knowledge resources.
Competitive compensation package with health insurance, wellness programs, and performance incentives.
Collaborative and inclusive work environment that encourages professional growth.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Siliguri |Illinois :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
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Canada |Quebec :
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Brussels |Antwerp :
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Brazil | Sao paulo |Attica :
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Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Japan | Saitama |Tokyo :
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